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Saturday, 6 October 2012

Ibuprohm

Ingredient matches for Ibuprohm

Ibuprofen

Ibuprofen is reported as an ingredient of Ibuprohm in the following countries:

United States

International Drug Name Search

Friday, 5 October 2012

Tamiflu 30 mg and 45 mg Hard Capsules

1. Name Of The Medicinal Product

Tamiflu 30 mg hard capsule.

Tamiflu 45 mg hard capsule.

2. Qualitative And Quantitative Composition

Tamiflu 30 mg hard capsule: Each hard capsule contains oseltamivir phosphate equivalent to 30 mg of oseltamivir.

Tamiflu 45 mg hard capsule: Each hard capsule contains oseltamivir phosphate equivalent to 45 mg of oseltamivir.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Hard capsule

Tamiflu 30 mg hard capsule: The hard capsule consists of a light yellow opaque body bearing the imprint “ROCHE” and a light yellow opaque cap bearing the imprint “30 mg”. Imprints are blue.

Tamiflu 45 mg hard capsule: The hard capsule consists of a grey opaque body bearing the imprint “ROCHE” and a grey opaque cap bearing the imprint “45 mg”. Imprints are blue.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of influenza

In patients one year of age and older who present with symptoms typical of influenza, when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms. This indication is based on clinical studies of naturally occurring influenza in which the predominant infection was influenza A (see section 5.1).

Tamiflu is indicated for the treatment of infants below 12 months of age during a pandemic influenza outbreak (see section 5.2).

Prevention of influenza

- Post-exposure prevention in individuals one year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community.

- The appropriate use of Tamiflu for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protection. In exceptional situations (e.g., in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in individuals one year of age or older.

- Tamiflu is indicated for post-exposure prevention of influenza in infants below 12 months of age during a pandemic influenza outbreak (see section 5.2).

Tamiflu is not a substitute for influenza vaccination.

The use of antivirals for the treatment and prevention of influenza should be determined on the basis of official recommendations. Decisions regarding the use of oseltamivir for treatment and prophylaxis should take into consideration what is known about the characteristics of the circulating influenza viruses, available information on influenza drug susceptibility patterns for each season and the impact of the disease in different geographical areas and patient populations (see section 5.1).

Based on limited pharmacokinetic and safety data, Tamiflu can be used in infants below 12 months of age for treatment during a pandemic influenza outbreak. The treating physician should take into account the pathogenicity of the circulating strain and the underlying condition of the patient to ensure there is a potential benefit to the child.

4.2 Posology And Method Of Administration

Tamiflu capsules and Tamiflu suspension are bioequivalent formulations. 75 mg doses can be administered as either

- one 75 mg capsule or

- one 30 mg capsule plus one 45 mg capsule or

- by administering one 30 mg dose plus one 45 mg dose of suspension.

Adults, adolescents or children (1 year of age or older) who are unable to swallow capsules may receive appropriate doses of Tamiflu suspension.

For infants below 1 year of age: In the absence of a suitable formulation, a pharmacy compounded preparation should preferentially be used as the syringe provided in the Tamiflu 12 mg/ml powder for oral suspension pack (with mg markings) does not allow for appropriate dose adjustments and commercially available syringes (with ml markings) may lead to unacceptable dosing inaccuracies (see below 4.2).

Treatment of influenza

Treatment should be initiated as soon as possible within the first two days of onset of symptoms of influenza.

• For adolescents (13 to 17 years of age) and adults: The recommended oral dose is 75 mg oseltamivir twice daily for 5 days.

• For infants older than 1 year of age and for children 2 to 12 years of age: Tamiflu 30 mg and 45 mg capsules and oral suspension are available.

The following weight-adjusted dosing regimens are recommended for children 1 year of age and older:

Body Weight	Recommended dose for 5 days
	30 mg twice daily
> 15 kg to 23 kg	45 mg twice daily
> 23 kg to 40 kg	60 mg twice daily
> 40 kg	75 mg twice daily

Children who are able to swallow capsules may receive treatment with Tamiflu capsules (30 mg, 45 mg, 75 mg) twice daily for 5 days as an alternative to the recommended dose of Tamiflu suspension.

• For infants below 12 months of age: The recommended treatment dose for infants less than 12 months is between 2 mg/kg twice daily and 3 mg/kg twice daily during a pandemic influenza outbreak. This is based upon limited pharmacokinetic data indicating that these doses provide plasma drug exposures in the majority of patients similar to those shown to be clinically efficacious in older children and adults (see section 5.2). The following weight-adjusted dosing regimens are recommended for treatment of infants below 1 year of age:

Age	Recommended dose for 5 days
> 3 months to 12 months	3 mg/kg twice daily
> 1 month to 3 months	2.5 mg/kg twice daily
0 to 1 month*	2 mg/kg twice daily

* There is no data available regarding the administration of Tamiflu to infants less than one month of age.

Administration of Tamiflu to infants less than one year of age should be based upon the judgment of the physician after considering the potential benefit of treatment versus any potential risk to the infant.

These age-based dosing recommendations are not intended for premature infants, i.e. those with a postmenstrual age less than 37 weeks. Insufficient data are available for these patients, in whom different dosing may be required due to the immaturity of physiological functions

Prevention of influenza

Post-exposure prevention

• For adolescents (13 to 17 years of age) and adults: The recommended dose for prevention of influenza following close contact with an infected individual is 75 mg oseltamivir once daily for 10 days. Therapy should begin as soon as possible within two days of exposure to an infected individual.

• For infants older than 1 year of age and for children 2 to 12 years of age: Tamiflu 30 mg and 45 mg capsules and oral suspension are available.

The recommended post-exposure prevention dose of Tamiflu is:

Body Weight	Recommended dose for 10 days
	30 mg once daily
> 15 kg to 23 kg	45 mg once daily
> 23 kg to 40 kg	60 mg once daily
> 40 kg	75 mg once daily

Children who are able to swallow capsules may receive prevention Tamiflu capsules (30 mg, 45 mg, 75 mg) once daily for 10 days as an alternative to the recommended dose of Tamiflu suspension.

• For infants below 12 months of age: The recommended prophylaxis dose for infants less than 12 months during a pandemic influenza outbreak is half of the daily treatment dose. This is based upon clinical data in children > 1 year of age and adults showing that a prophylaxis dose equivalent to half the daily treatment dose is clinically efficacious for the prevention of influenza. The following weight-adjusted dosing prophylaxis regimens are recommended for infants below 1 year of age:

Age	Recommended dose for 10 days
> 3 months to 12 months	3 mg/kg once daily
> 1 month to 3 months	2.5 mg/kg once daily
0 to 1 month*	2 mg/kg once daily

* There is no data available regarding the administration of Tamiflu to infants less than one month of age.

Administration of Tamiflu to infants less than one year of age should be based upon the judgment of the physician after considering the potential benefit of prophylaxis versus any potential risk to the infant.

Prevention during an influenza epidemic in the community

The recommended dose for prevention of influenza during a community outbreak is 75 mg oseltamivir once daily for up to 6 weeks.

Extemporaneous formulation

When Tamiflu powder for oral suspension is not available

When commercially manufactured Tamiflu powder for oral suspension is not available, patients who are unable to swallow capsules may receive appropriate doses of Tamiflu prepared in a pharmacy or prepared at home.

For infants below 12 months, the pharmacy preparation should be preferred to home preparation. Detailed information on the home preparation can be found in section 3 of the package leaflet of Tamiflu capsules.

Pharmacy compounding

• Adults and children greater than 1 year who are unable to swallow intact capsules

This procedure describes the preparation of a 15 mg/ml solution that will provide one patient with enough medication for a 5-day course of treatment or a 10-day course of prophylaxis.

The pharmacist may compound a suspension (15 mg/ml) from Tamiflu 30 mg, 45 mg or 75 mg capsules using water containing 0.1% w/v sodium benzoate added as a preservative.

First, calculate the Total Volume needed to be compounded and dispensed to provide a 5-day course of treatment or a 10=day course of prophylaxis for the patient. The Total Volume required is determined by the weight of the patient according to the recommendation in the table below:

Volume of Compounded Suspension (15 mg/ml) Prepared Based Upon the Patient's Weight

Body Weight (kg)	Total Volume to Compound per Patient Weight (ml)
10 to 15 kg	30 ml
> 15 to 23 kg	40 ml
> 23 to 40 kg	50 ml
> 40 kg	60 ml

Second, determine the number of capsules and the amount of vehicle (water containing 0.1% w/v sodium benzoate added as a preservative) that is needed to prepare the Total Volume (calculated from the table above: 30 ml, 40 ml, 50 ml or 60 ml) of compounded suspension (15 mg/ml) as shown in the table below:

Number of Capsules and Amount of Vehicle Needed to Prepare the Total Volume of a Compounded Suspension (15 mg/ml)

Total Volume of Compounded Suspension to be Prepared	Required Number of Tamiflu Capsules (mg of oseltamivir)	Required Volume of Vehicle
75 mg	45 mg	30 mg
30 ml	6 capsules (450 mg)	10 capsules (450 mg)	15 capsules (450 mg)	29 ml
40 ml	8 capsules (600 mg)	Please use alternative capsule strength*	20 capsules (600 mg)	38.5 ml
50 ml	10 capsules (750 mg)	Please use alternative capsule strength*	25 capsules (750 mg)	48 ml
60 ml	12 capsules (900 mg)	20 capsules (900 mg)	30 capsules (900 mg)	57 ml

* No integral number of capsules can be used to achieve the target concentration; therefore, please use either the 30 mg or 75 mg capsules.

Third, follow the procedure below for compounding the suspension (15 mg/ml) from Tamiflu capsules:

1. Carefully separate the capsule body and cap and transfer the contents of the required number of Tamiflu capsules into a clean mortar.

2. Triturate the granules to a fine powder.

3. Add one-third (1/3) of the specified amount of vehicle (water containing 0.1% w/v sodium benzoate added as a preservative) and triturate the powder until a uniform suspension is achieved.

4. Transfer the suspension to an amber glass or amber polyethyleneterephthalate (PET) bottle. A funnel may be used to eliminate any spillage.

5. Add another one-third (1/3) of the vehicle to the mortar, rinse the pestle and mortar by a triturating motion and transfer the vehicle into the bottle.

6. Repeat the rinsing (Step 5) with the remainder of the vehicle.

7. Close the bottle using a child-resistant cap.

8. Shake well to completely dissolve the active drug and to ensure homogeneous distribution of the dissolved drug in the resulting suspension.

(Note: Undissolved residue may be visible but is comprised of inert ingredients of Tamiflu capsules, which are insoluble. However, the active drug, oseltamivir phosphate, readily dissolves in the specified vehicle and therefore forms a uniform solution.)

9. Put an ancillary label on the bottle indicating “Shake Gently Before Use”.

10. Instruct the parent or caregiver that after the patient has completed the full course of therapy any remaining solution must be discarded. It is recommended that this information be provided by affixing an ancillary label to the bottle or adding a statement to the pharmacy label instructions.

11. Place an appropriate expiration date label according to storage condition (see below).

Storage of the pharmacy-compounded suspension (15 mg/ml)

Room temperature storage conditions: Stable for 3 weeks (21 days) when stored at room temperature “do not store above 25 °C”.

Refrigerated storage conditions: Stable for 6 weeks when stored at 2 °C - 8 °C.

Place a pharmacy label on the bottle that includes the patient's name, dosing instructions, use by date, drug name and any other required information to be in compliance with local pharmacy regulations. Refer to the table below for the proper dosing instructions.

Dosing Chart for Pharmacy-Compounded Suspension from Tamiflu Capsules for Children One Year of Age or Older

Body Weight (kg)	Dose (mg)	Volume per Dose 15 mg/ml	Treatment Dose (for 5 days)	Prophylaxis Dose (for 10 days)
10 kg to 15 kg	30 mg	2 ml	2 ml twice daily	2 ml once daily
> 15 to 23 kg	45 mg	3 ml	3 ml twice daily	3 ml once daily
> 23 to 40 kg	60 mg	4 ml	4 ml twice daily	4 ml once daily
> 40 kg	75 mg	5 ml	5 ml twice daily	5 ml once daily

Note: This compounding procedure results in a 15 mg/ml suspension, which is different from the commercially available Tamiflu powder for oral suspension.

Dispense the suspension with a graduated oral syringe for measuring small amounts of suspension. If possible, mark or highlight the graduation corresponding to the appropriate dose (2 ml, 3 ml, 4 ml or 5 ml) on the oral syringe for each patient.

The appropriate dose must be mixed by the caregiver with an equal quantity of sweet liquid food, such as sugar water, chocolate syrup, cherry syrup, dessert toppings (like caramel or fudge sauce) to mask the bitter taste.

• Infants less than 1 year of age

This procedure describes the preparation of a 10 mg/ml solution that will provide one patient with enough medication for a 5-day course of treatment or a 10-day course of prophylaxis.

The pharmacist may compound a suspension (10 mg/ml) from Tamiflu 30 mg, 45 mg or 75 mg capsules using water containing 0.1% w/v sodium benzoate added as a preservative.

First, calculate the Total Volume needed to be compounded and dispensed for each patient. The Total Volume required is determined by the weight of the patient according to the recommendation in the table below:

Volume of Compounded Suspension (10 mg/ml) Prepared Based Upon the Patient's Weight

Body Weight

(kg)

Total Volume to Compound per Patient Weight

(ml)

30 ml

> 7 to 12 kg

45 ml

Second, determine the number of capsules and the amount of vehicle (water containing 0.1% w/v sodium benzoate added as a preservative) that is needed to prepare the Total Volume (calculated from the table above: 30 ml, 45 ml) of compounded suspension (10 mg/ml) as shown in the table below:

Number of Capsules and Amount of Vehicle Needed to Prepare the Total Volume of a Compounded Suspension (10 mg/ml)

Total Volume of Compounded Suspension to be Prepared	Required Number of Tamiflu Capsules (mg of oseltamivir)	Required Volume of Vehicle
75 mg	45 mg	30 mg
30 ml	4 capsules (300 mg)	Please use alternative capsule strength*	10 capsules (300 mg)	29.5 ml
45 ml	6 capsules (450 mg)	10 capsules (450 mg)	15 capsules (450 mg)	44 ml

* No integral number of capsules can be used to achieve the target concentration; therefore, please use either the 30 mg or 75 mg capsules.

Third, follow the procedure below for compounding the suspension (10 mg/ml) from Tamiflu capsules:

1. Carefully separate the capsule body and cap and transfer the contents of the required number of Tamiflu capsules into a clean mortar.

2. Triturate the granules to a fine powder.

3. Add one-third (1/3) of the specified amount of vehicle and triturate the powder until a uniform suspension is achieved.

4. Transfer the suspension to an amber glass or amber polyethyleneterephthalate (PET) bottle. A funnel may be used to eliminate any spillage.

5. Add another one-third (1/3) of the vehicle to the mortar, rinse the pestle and mortar by a triturating motion and transfer the vehicle into the bottle.

6. Repeat the rinsing (Step 5) with the remainder of the vehicle.

7. Close the bottle using a child-resistant cap.

8. Shake well to completely dissolve the active drug and to ensure homogeneous distribution of the dissolved drug in the resulting suspension.

9. Put an ancillary label on the bottle indicating “Shake Gently Before Use”.

11. Place an appropriate expiration date label according to storage condition (see below).

Storage of the pharmacy-compounded suspension (10 mg/ml)

Room temperature storage conditions: Stable for 3 weeks (21 days) when stored at room temperature “do not store above 25 °C”.

Refrigerated storage conditions: Stable for 6 weeks when stored at 2 °C - 8 °C.

Dosing Chart for Pharmacy-Compounded Suspension (10 mg/ml) from Tamiflu Capsules for Infants Less Than One Month of Age

Body Weight (rounded to the nearest 0.5 kg)	Treatment Dose (for 5 days)	Prophylaxis Dose (for 10 days)
3 kg	0.60 ml twice daily	0.60 ml once daily
3.5 kg	0.70 ml twice daily	0.70 ml once daily
4 kg	0.80 ml twice daily	0.80 ml once daily
4.5 kg	0.90 ml twice daily	0.90 ml once daily

Dosing Chart for Pharmacy-Compounded Suspension (10 mg/ml) from Tamiflu Capsules for Infants One to Twelve Months of Age

Body Weight (rounded to the nearest 0.5 kg)	Treatment Dose (for 5 days)	Prophylaxis Dose (for 10 days)
4 kg	1.00 ml twice daily	1.00 ml once daily
4.5 kg	1.10 ml twice daily	1.10 ml once daily
5 kg	1.30 ml twice daily	1.30 ml once daily
5.5 kg	1.40 ml twice daily	1.40 ml once daily
6 kg	1.50 ml twice daily	1.50 ml once daily
7 kg	2.10 ml twice daily	2.10 ml once daily
8 kg	2.40 ml twice daily	2.40 ml once daily
9 kg	2.70 ml twice daily	2.70 ml once daily
	3.00 ml twice daily	3.00 ml once daily

Note: This compounding procedure results in a 10 mg/ml suspension, which is different from the commercially available Tamiflu powder for oral suspension.

Home preparation

When commercially manufactured Tamiflu oral suspension is not available, a pharmacy preparation from Tamiflu capsules can be used (detailed instructions above in section 4.2). If the pharmacy preparation is not available either, Tamiflu doses may be prepared at home. The pharmacy preparation is the preferred option in infants below 12 months of age.

When appropriate capsule strengths are available, the dose is given by opening the capsule and mixing its contents with no more than one teaspoon of a suitable sweetened food product. The bitter taste can be masked by products such as sugar water, chocolate syrup, cherry syrup, dessert toppings (like caramel or fudge sauce). The mixture should be stirred and given entirely to the patient. The mixture must be swallowed immediately after its preparation.

When only 75 mg capsules are available, and doses of 30 mg or 45 mg are needed, the preparation involves additional steps. Detailed instructions can be found in section 3 in the package leaflet of Tamiflu capsules.

Special populations

Hepatic impairment

No dose adjustment is required either for treatment or for prevention in patients with hepatic dysfunction. No studies have been carried out in paediatric patients with hepatic disorder.

Renal impairment

Treatment of influenza: Dose adjustment is recommended for adults with moderate or severe renal impairment. Recommended doses are detailed in the table below.

Creatinine clearance	Recommended dose for treatment
> 60 (ml/min)	75 mg twice daily
> 30 to 60 (ml/min)	30 mg (suspension or capsules) twice daily
> 10 to 30 (ml/min)	30 mg (suspension or capsules) once daily
	Not recommended (no data available)
Hemodialysis patients	30 mg after each hemodialysis session
Peritoneal dialysis patients*	30 mg (suspension or capsules) single dose

* Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients; the clearance of oseltamivir carboxylate is expected to be higher when automated peritoneal dialysis (APD) mode is used. Treatment mode can be switched from APD to CAPD if considered necessary by a nephrologist.

Prevention of influenza: Dose adjustment is recommended for adults with moderate or severe renal impairment as detailed in the table below.

Creatinine clearance	Recommended dose for prevention
> 60 (ml/min)	75 mg once daily
> 30 to 60 (ml/min)	30 mg (suspension or capsules) once daily
> 10 to 30 (ml/min)	30 mg (suspension or capsules) every second day
	Not recommended (no data available)
Hemodialysis patients	30 mg after every second hemodialysis session
Peritoneal dialysis patients*	30 mg (suspension or capsules) once weekly

Elderly

No dose adjustment is required, unless there is evidence of severe renal impairment.

Children

There is insufficient clinical data available in children with renal impairment to be able to make any dosing recommendation.

Immunocompromised patients

Longer duration of seasonal prophylaxis up to 12 weeks has been evaluated in immunocompromised patients (see sections 4.4, 4.8 and 5.1).

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

4.4 Special Warnings And Precautions For Use

Oseltamivir is effective only against illness caused by influenza viruses. There is no evidence for efficacy of oseltamivir in any illness caused by agents other than influenza viruses.

No information is available regarding the safety and efficacy of oseltamivir in patients with any medical condition sufficiently severe or unstable to be considered at imminent risk of requiring hospitalisation.

The efficacy of oseltamivir in either treatment or prophylaxis of influenza in immunocompromised patients has not been firmly established (see section 5.1).

Efficacy of oseltamivir in the treatment of subjects with chronic cardiac disease and/or respiratory disease has not been established. No difference in the incidence of complications was observed between the treatment and placebo groups in this population (see section 5.1).

No data allowing a dose recommendation for premature children (< 37 weeks post-menstrual age*) are currently available.

* Time between first day of last normal menstrual period and day of assessment, gestational age plus post-natal age.

Tamiflu is not a substitute for influenza vaccination. Use of Tamiflu must not affect the evaluation of individuals for annual influenza vaccination. The protection against influenza lasts only as long as Tamiflu is administered. Tamiflu should be used for the treatment and prevention of influenza only when reliable epidemiological data indicate that influenza virus is circulating in the community.

Susceptibility of circulating influenza virus strains to oseltamivir has been shown to be highly variable (see section 5.1). Therefore, prescribers should take into account the most recent information available on oseltamivir susceptibility patterns of the currently circulating viruses when deciding whether to use Tamiflu.

Severe renal impairment

Dose adjustment is recommended for both treatment and prevention in adults with sev

Monday, 1 October 2012

Neosar oral/injection

Generic Name: cyclophosphamide (oral/injection) (sye kloe FOSS fah mide)

Brand Names: Cytoxan, Cytoxan Lyophilized, Neosar

What is cyclophosphamide?

Cyclophosphamide is a cancer (chemotherapeutic) medication. Cyclophosphamide interferes with the growth of cancer cells and slows their growth and spread in the body.

Cyclophosphamide is used to treat several types of cancer. Cyclophosphamide is also used to treat certain cases of nephrotic syndrome (kidney disease) in children.

Cyclophosphamide may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about cyclophosphamide?

Cyclophosphamide should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of cyclophosphamide including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection such as fever; chills, or sore throat); bladder problems; and others. Talk to your doctor about the possible side effects from treatment with cyclophosphamide.

In some cases, secondary cancers have been reported to occur during and following treatment with cyclophosphamide. Talk to your doctor about the risks and benefits of this medication.

What should I discuss with my healthcare provider before taking cyclophosphamide?

Before taking cyclophosphamide, tell your doctor if you

have an infection or have had recent vaccinations;

have a low level of white blood cells or platelets (detected by blood tests);

have bone marrow problems;

have been previously treated with x-ray therapy;

have been previously treated with other chemotherapy medicines (i.e., Alkeran, CeeNU, Leukeran, Myleran, and others);

have had your adrenal glands removed;

need to have surgery;

have any unhealed wounds;

have a history of heart disease;

have liver disease; or

have kidney disease.

You may not be able to take cyclophosphamide, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Cyclophosphamide is in the FDA pregnancy category D. This means that cyclophosphamide is known to be harmful to an unborn baby. Cyclophosphamide may also affect egg production in women and sperm production in men. Do not take cyclophosphamide without first talking to your doctor if you are pregnant or could become pregnant during treatment. Use of cyclophosphamide by the father prior to conception has also been associated with birth defects. Contraceptive measures are recommended during treatment with cyclophosphamide for both men and women. Cyclophosphamide passes into breast milk and may harm a nursing infant. Do not take cyclophosphamide without first talking to your doctor if you are breast feeding a baby.

How should I take cyclophosphamide?

Take cyclophosphamide exactly as directed by your doctor. If you do not understand these instructions, ask your doctor, nurse or pharmacist to explain them to you.

Take each oral dose with a large glass of water.

To avoid urinary bladder irritation during treatment with either oral or injectable cyclophosphamide, drink plenty of fluid during treatment and for 48 hours following treatment, usually 7 to 12 cups (3 quarts) per day, and empty your bladder frequently, every 2 to 3 hours including once during the night.

Taking oral cyclophosphamide on an empty stomach is preferable. If severe stomach upset occurs, take cyclophosphamide with food. Continue to take cyclophosphamide even if nausea and vomiting occurs. Do not stop taking the medicine without first talking to your doctor. Check with your doctor if vomiting occurs shortly after taking a dose of cyclophosphamide. Your doctor may want you to take another dose, but do not do this without checking with your doctor first.

If you are taking a liquid form of cyclophosphamide by mouth, use a dose measuring spoon or cup to ensure that you get the correct dose.

Injectable cyclophosphamide should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Your doctor will determine the correct amount and frequency of treatment with cyclophosphamide depending upon the type of cancer being treated and other factors. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.

Your doctor will probably want you to have regularly scheduled blood tests and other medical evaluations during treatment with cyclophosphamide to monitor progress and side effects.

Store cyclophosphamide oral tablets at or below 77 degrees Fahrenheit (25 degrees Celsius). Brief exposures to 86 degrees Fahrenheit (30 degrees Celsius) are permitted but the tablets should be protected from temperatures above 86 degrees Fahrenheit. Your healthcare provider will store cyclophosphamide injection as directed by the manufacturer. If you are storing cyclophosphamide injection at home, follow the directions provided by your healthcare provider. Store cyclophosphamide oral liquid in a glass container in the refrigerator for up to 14 days.

What happens if I miss a dose?

Take the missed oral dose as soon as you remember. If it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose as directed. Do not take a double dose of this medication.

Contact your doctor if you miss a dose of cyclophosphamide injection.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a cyclophosphamide overdose may include decreased bone marrow function, infection, and heart problems.

What should I avoid while taking cyclophosphamide?

Cyclophosphamide can lower the activity of the immune system making you more susceptible to infection. Avoid contact with people who have colds, the flu, or other contagious illnesses. In addition, do not receive vaccines that contain a live strain of the virus (e.g., live oral polio vaccine) and avoid contact with individuals who have recently been vaccinated with a live virus.

Cyclophosphamide side effects

If you experience any of the following serious side effects, seek emergency medical attention or contact your doctor immediately:

an allergic reaction (shortness of breath; closing of your throat; difficulty breathing; swelling of your lips, face, or tongue; or hives);

blood in the urine;

black or tarry stools;

painful or difficult urination;

signs of infection such as fever; chills, or sore throat;

jaundice (yellowing of the skin or eyes);

lower back or side pain;

chest pain, difficulty breathing, or swelling;

unusual bleeding or bruising; or

changes in bone marrow function (detected by blood tests).

Other less serious side effects may be more likely to occur. Talk to your doctor if you experience

nausea, vomiting, or decreased appetite;

mouth sores;

abdominal pain;

diarrhea;

temporary hair loss;

temporary or permanent sterility;

rash;

changes in skin color; or

changes in nails.

In some cases, secondary cancers have been reported to occur during and following treatment with cyclophosphamide. Talk to your doctor about the risks and benefits of this medication.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect cyclophosphamide?

Before taking cyclophosphamide, tell your doctor if you are taking any other medicines, especially any of the following:

phenobarbital (Luminal, Solfoton);

allopurinol (Zyloprim);

digoxin (Lanoxin);

warfarin (Coumadin);

a thiazide diuretic (water pill) such as chlorothiazide (Diuril), hydrochlorothiazide (HCTZ, HydroDiuril, Esidrix, Microzide, Oretic), chlorthalidone (Hygroton, Thalitone), indapamide (Lozol), metolazone (Mykrox, Zaroxolyn), and others; or

another chemotherapy medicine.

You may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Do not receive "live" vaccines during treatment with cyclophosphamide. Administration of a live vaccine may be dangerous during treatment with cyclophosphamide.

Other drugs may interact with cyclophosphamide. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including herbal products, during treatment with cyclophosphamide.

More Neosar resources

Neosar Side Effects (in more detail)
Neosar Use in Pregnancy & Breastfeeding
Neosar Drug Interactions
Neosar Support Group
0 Reviews for Neosar - Add your own review/rating

Compare Neosar with other medications

Acute Lymphocytic Leukemia
Acute Nonlymphocytic Leukemia
Bladder Cancer
Brain Tumor
Breast Cancer
Cancer
Cervical Cancer
Chronic Lymphocytic Leukemia
Chronic Myelogenous Leukemia
Cogan's Syndrome
Dermatomyositis
Endometrial Cancer
Ewing's Sarcoma
Histiocytosis
Hodgkin's Lymphoma
IgA Nephropathy
Multiple Myeloma
Multiple Sclerosis
Mycosis Fungoides
Nephrotic Syndrome
Neuroblastoma
Non-Hodgkin's Lymphoma
Non-Small Cell Lung Cancer
Organ Transplant, Rejection Prophylaxis
Osteosarcoma
Ovarian Cancer
Prostate Cancer
Rheumatoid Arthritis
Small Cell Lung Cancer
Systemic Lupus Erythematosus
Systemic Sclerosis
Testicular Cancer
Wegener's Granulomatosus
Wilms' Tumor

Where can I get more information?

Your pharmacist has additional information about cyclophosphamide written for health professionals that you may read.

See also: Neosar side effects (in more detail)

Sunday, 30 September 2012

Dulcolax Suppositories 10mg Dulcolax Suppositories for Children 5mg

Dulcolax Suppositories 10 mg

Dulcolax Suppositories for Children 5 mg

bisacodyl

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. You need to use DULCOLAX Suppositories as instructed in this leaflet to get the best results from it.

Keep this leaflet. You may need to read it again

Ask your pharmacist if you need more information or advice

You must contact your pharmacist or doctor if your symptoms worsen or do not improve after 5 days of treatment

If a side effect occurs and gets troublesome, or seems serious to you, or if you experience any side effect not listed in this leaflet, please tell your pharmacist or doctor

In this leaflet:

1. What DULCOLAX Suppositories are and what they are used for

2. Before you use DULCOLAX Suppositories

3. How to use DULCOLAX Suppositories

4. Possible side effects

5. How to store DULCOLAX Suppositories

6. Further information

What Dulcolax Suppositories Are And What They Are Used For

DULCOLAX Suppositories contain a medicine called bisacodyl. This belongs to a group of medicines called laxatives.

DULCOLAX Suppositories are used for relief of constipation

DULCOLAX Suppositories are also used in hospitals to clear the bowel before surgery, X-rays or other tests

DULCOLAX Suppositories stimulate the muscles of the bowel (large intestine), helping to return the body to its natural rhythm. They have a laxative effect usually within 30 minutes

What is constipation?

Normal and regular bowel movement is important for most people. However, what is “normal and regular” varies from person to person. Some may have a bowel movement every day, others less often. Whatever it is like for you, it is best that your bowel movement has a regular pattern.

Constipation is an occasional problem for some people; for others, it may happen more often

It happens when the normal muscle actions in the bowel (large intestine) slow down. This can mean that the material is not easily eliminated from the body

The cause of constipation is often not known. It can be associated with:

Sudden change of diet

A diet with not enough fibre

Loss of ‘tone’ of the bowel muscles in older people

Pregnancy

Medicines such as morphine or codeine

Having to stay in bed for a long time

Lack of exercise

Whatever the cause, constipation is uncomfortable. It may make you feel bloated and heavy, or generally “off colour”. Sometimes it causes headaches.

These healthy tips are recommended to try and prevent constipation happening:

Eat a balanced diet including fresh fruit and vegetables

Drink enough water so that you do not become dehydrated

Keep up your exercise and stay fit

Make time to empty your bowels when your body tells you

Before You Use Dulcolax Suppositories

Do not use DULCOLAX Suppositories if:

You are allergic (hypersensitive) to bisacodyl or hard fat

You have severe dehydration

You have a bowel condition called “ileus” (in the small intestine)

You have a serious abdominal condition such as appendicitis

You have severe abdominal pain with nausea and vomiting

You have a blocked bowel (intestinal obstruction)

You have inflammation of the bowel (small or large intestine)

You have cracking of the skin around your back passage (anal fissures)

You have inflammation or ulcers around your back passage (ulcerative proctitis)

Do not use DULCOLAX Suppositories if any of the above applies to you. If you are not sure, talk to your pharmacist or doctor before using this medicine.

Taking other medicines

Please tell your pharmacist or doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because DULCOLAX Suppositories can affect the way some other medicines work. Also, some other medicines can affect the way DULCOLAX Suppositories work.

In particular, tell your pharmacist or doctor if you are taking any of the following medicines:

Water tablets (diuretics) such as bendrofluazide or furosemide (frusemide)

Steroid medicines such as prednisolone

Before using DULCOLAX Suppositories, tell your pharmacist or doctor if you are not sure if any of the above applies to you.

Pregnancy and breast-feeding

Talk to your pharmacist or doctor before using DULCOLAX Suppositories if you are pregnant, planning to become pregnant or are breast-feeding.

How To Use Dulcolax Suppositories

If this medicine is from your doctor or pharmacist, do exactly as they have told you. Otherwise, follow the instructions below. If you do not understand the instructions, or if you are not sure, ask your pharmacist or doctor.

As with all laxatives, DULCOLAX Suppositories should not be used every day for more than 5 days. If you need laxatives every day, or if you have abdominal pain which does not go away, you should see your doctor.

How to use the suppositories

The suppositories should only be used in your back passage.

1. Take off the foil wrapping

2. Lie on one side and pull your knees up towards your chest. Keep one leg drawn up more than the other

3. Use your first finger (index finger) or middle finger to push in the suppository

4. Gently push the suppository as far as possible into your back passage, pointed end first

5. Once it is as far as it will go, push it side-ways to make sure it touches the wall of the bowel

6. Lower your legs to a comfortable position whilst the suppository is retained in place

7. Keep the suppository inside you for at least 30 minutes

If you feel the suppository might come out straight away:

You may not have put it in high enough. Push it in as far as possible

Try to keep it in for 30 minutes, even if you feel like you urgently need to go to the toilet. This is how long it takes to work

How much to use

For constipation

Adults and children over 10 years

Put one 10 mg suppository into the back passage for immediate effect. Only use one suppository per day

Children under 10 years

DULCOLAX Suppositories for Children 5 mg should only be used if recommended by a doctor. The usual dose is:

Put one 5 mg suppository into the back passage for immediate effect. Only use one suppository per day

For bowel clearance before surgery, X-rays or other tests

In hospitals, when patients are being prepared for surgery, X-rays or other tests, DULCOLAX Suppositories and DULCOLAX Tablets are both used. This helps to get complete bowel clearance.

Adults and children over 10 years

Take two tablets in the morning and two tablets in the evening and use one 10 mg suppository on the following morning

Children 4 -10 years

Give one tablet in the evening and one 5 mg suppository (DULCOLAX Suppositories for Children) on the following morning

If you use more DULCOLAX Suppositories than you should

If you use more of this medicine than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. This is so the doctor knows what you have used.

If you have any questions on the use of this product, ask your pharmacist or doctor.

Possible Side Effects

Like all medicines, DULCOLAX Suppositories can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Common side effects (affect less than 1 in 10 people)

Abdominal cramps or pain

Nausea

Diarrhoea

Uncommon side effects (affect less than 1 in 100 people)

Vomiting

Abdominal discomfort

Blood in the stools (usually mild and self-limiting)

Discomfort inside and around the back passage

Rare side effects (affect less than 1 in 1000 people)

Allergic reactions which may cause a skin rash or itching

Unknown – incidence of side effect cannot be estimated from the available data

Colitis (inflammation of the large intestine which causes abdominal pain or diarrhoea)

Dehydration which can make you feel thirsty and produce less urine. If you are dehydrated drink plenty of liquid.

Serious allergic reactions which may cause swelling of the face or throat and difficulty in breathing or dizziness. If you have a severe allergic reaction, stop taking this medicine and see a doctor straight away.

If a side effect occurs and gets troublesome or seems serious to you, or if you experience any side effect not listed in this leaflet, please tell your pharmacist or doctor.

How To Store Dulcolax Suppositories

Keep this medicine out of the sight and reach of children

Do not use DULCOLAX Suppositories after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C

The suppositories should be protected from light. Keep them in the outer carton

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment

Further Information

What DULCOLAX Suppositories contain

DULCOLAX Suppositories 10 mg contain 10 mg of the active ingredient bisacodyl

DULCOLAX Suppositories for Children 5 mg contain 5 mg of the active ingredient bisacodyl

Both the suppositories are made from hard fat, which is an ingredient needed to mould the suppository into the correct shape

What DULCOLAX Suppositories look like and contents of the pack

The suppositories are white and torpedo shaped

DULCOLAX Suppositories 10 mg are available in packs of 12

DULCOLAX Suppositories for Children 5 mg are available in packs of 5

Marketing Authorisations are held by:

Boehringer Ingelheim Limited

Consumer Healthcare

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

United Kingdom

DULCOLAX Suppositories are manufactured by:

Instituto De Angeli. S.r.I.

Localitá Prulli di Sotto n. 103/c

Regello (Fl)

Italy

This leaflet was revised in May 2010.

Registered trade mark

XXXXXX/GB/7

20080918

Capoten

Generic Name: Captopril
Class: Angiotensin-Converting Enzyme Inhibitors
VA Class: CV800
CAS Number: 62571-86-2

May cause fetal and neonatal morbidity and mortality if used during pregnancy.⁴⁰¹ ⁴⁰² (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

If pregnancy is detected, discontinue captopril as soon as possible.¹¹⁵ ⁴⁰²

Introduction

Sulfhydryl ACE inhibitor.¹ ³ ⁴ ⁵

Uses for Capoten

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).¹⁰⁰ ¹¹⁵ ²¹⁵ ²⁵⁹ ³¹⁶ ³¹⁷

One of several preferred initial therapies in hypertensive patients with heart failure, postmyocardial infarction, high coronary disease risk, diabetes mellitus, chronic renal failure, and/or cerebrovascular disease.³⁸²

Can be used as monotherapy for initial management of uncomplicated hypertension;¹¹⁵ however, thiazide diuretics are preferred by JNC 7.³⁸²

Nephropathy

Stabilization or improvement of effective renal blood flow and glomerular filtration rate and reduction of proteinuria in hypertensive¹¹⁵ ¹⁴¹ ¹⁴² ¹⁴³ ¹⁷⁴ ¹⁸⁷ ¹⁸⁸ ¹⁸⁹ ²⁸¹ ³²³ or normotensive¹¹⁵ ¹⁶² patients with moderately impaired renal function,¹⁴¹ ¹⁴³ ¹⁷⁴ ³²³ moderate to severe renal disease,¹⁴¹ ³²³ or diabetic nephropathy.¹⁴¹ ¹⁴² ¹⁴³ ¹⁸⁷ ¹⁸⁸ ¹⁸⁹ ²⁶⁸ ³³⁴

CHF

Management of symptomatic CHF, usually in conjunction with cardiac glycosides, diuretics, and β-adrenergic blocking agents.¹¹⁵ ²¹⁰ ²⁴⁶ ²⁴⁷ ²⁴⁸ ²⁴⁹ ²⁵⁰ ²⁵² ²⁵³ ²⁵⁴ ²⁵⁶ ²⁵⁷ ²⁹² ³⁰⁴ ³¹⁹ ³²⁰ ³²¹ ³³³ ³⁷⁷

Left Ventricular Dysfunction after AMI

Treatment of clinically stable patients with left ventricular dysfunction (ejection fraction ≤40%) to improve survival following MI and to reduce the incidence of overt heart failure and subsequent hospitalizations for CHF.¹¹⁵ ³¹⁹ ³²¹ ³⁷⁴

Capoten Dosage and Administration

Administration

Oral Administration

Administer orally 1 hour before meals to maximize absorption.¹¹⁵

Dosage

Pediatric Patients

Hypertension

Oral

Dosage has been reduced in proportion to body weight; titrate carefully.¹¹⁵ Some experts recommend an initial dosage of 0.9–1.5 mg/kg daily (given as 0.3–0.5 mg/kg 3 times daily).³⁹⁸ Increase dosage as necessary to a maximum of 6 mg/kg daily.³⁹⁸

Adults

Hypertension

Oral

Initially, 25 mg 2 or 3 times daily.¹¹⁵ ³¹⁶ ³⁸² If BP is not adequately controlled after 1–2 weeks, increase dosage to 50 mg 2 or 3 times daily.¹¹⁵

Lower initial dosages (e.g., 6.25 mg twice daily to 12.5 mg 3 times daily) may be effective in some patients, particularly those already receiving a diuretic.^a (See Hypotension under Cautions.)

Usual dosage: Manufacturers recommend 25–150 mg 2 or 3 times daily (usually not necessary to exceed 450 mg daily).¹¹⁵ ³¹⁶ JNC 7 recommends 25–100 mg daily given in 2 divided doses; JNC 7 recommends adding another drug, if needed, rather than continuing to increase dosage.³⁸²

If combination therapy is initiated with captopril/hydrochlorothiazide fixed-combination preparation, captopril 25 mg and hydrochlorothiazide 15 mg daily initially;¹⁰² ²⁵⁹ adjust dosage (generally at 6-week intervals) by administering each drug separately or by advancing the fixed-combination preparation.¹⁰² ²⁵⁹

Hypertensive Crises

Oral

25 mg 2 or 3 times daily, initiated promptly under close supervision with frequent monitoring of BP.¹¹⁵ May continue previous diuretic therapy, but discontinue other hypotensive agents.¹¹⁵ May increase dosage at intervals of ≤24 hours under continuous supervision until optimum BP response is attained or 450 mg daily is given.¹¹⁵ Adjunctive therapy with other hypotensive agents may be necessary.^a

Acute therapy (e.g., 12.5–25 mg, repeated once or twice if necessary at intervals of 30–60 minutes or longer) has been effective²³¹ ²³² ²³⁶ ²⁵⁹ in adults with hypertensive urgencies†²³¹ ²³² ²⁵⁹ and emergencies†.²³³ ²³⁴ ²³⁵ ²³⁶ ²³⁷ ²³⁸ ²⁵⁹ ³¹⁰

Nephropathy

Diabetic Nephropathy

Oral

25 mg 3 times daily.¹¹⁵ ²⁶²

CHF

Oral

Manufacturers recommend initial dosage of 25 mg 3 times daily;¹¹⁵ in patients with normal or low BP who may be volume- and/or salt-depleted, initial dosage of 6.25 or 12.5 mg 3 times daily.¹¹⁵ Increase dosage gradually to 50 mg 3 times daily; delay further dosage increases for ≥2 weeks to assess response.¹¹⁵

Some clinicians recommend initial dosage of 6.25 or 12.5 mg 3 times daily, with gradual titration over several weeks to 50 mg 3 times daily, regardless of BP, salt/volume status, or concomitant diuretic therapy.³²¹ ³³³ ³⁷⁷ Generally titrate dosage to prespecified target (i.e., ≥150 mg daily) or highest tolerated dosage rather than according to response.³³³ ³⁷⁷

Left Ventricular Dysfunction after AMI

Oral

Manufacturers recommend initiation of therapy ≥3 days post-MI with single dose of 6.25 mg, followed by 12.5 mg 3 times daily.¹¹⁵ Increase dosage over next several days to 25 mg 3 times daily and then over next several weeks (as tolerated) to 50 mg 3 times daily.¹¹⁵

Some clinicians recommend initiation of therapy <24 hours post-MI with initial dose of 6.25 mg, followed by 12.5 mg 2 hours later, 25 mg 10–12 hours later, and then 50 mg twice daily as tolerated.³¹⁹ Recommended maintenance dosage: 50 mg 3 times daily.¹¹⁵

Prescribing Limits

Pediatric Patients

Hypertension

Oral

Maximum 6 mg/kg daily.³⁹⁸

Adults

Hypertension

Oral

Maximum 450 mg daily.¹¹⁵

Dosage of captopril/hydrochlorothiazide fixed-combination generally should not exceed captopril 150 mg and hydrochlorothiazide 50 mg daily.¹⁰²

CHF

Oral

Maximum dosage recommended by manufacturer and some experts is 450 mg daily.¹¹⁵ ³³³ Other experts suggest maximum dosage of 50 mg 3 times daily.³⁷⁷

Special Populations

Renal Impairment

Manufacturers recommend initial dosage of <75 mg daily; increase dosage in small increments at 1- to 2-week intervals.¹¹⁵ After desired therapeutic effect has been attained, slowly reduce dosage to minimum effective level.¹¹⁵

Patients with Cl_cr 10–50 mL/minute: 75% of usual captopril dosage or administration of usual dose every 12–18 hours suggested by some clinicians.²¹¹

Cl_cr <10 mL/minute: 50% of usual dosage or administration of usual dose every 24 hours suggested by some clinicians.²¹¹

Patients undergoing hemodialysis may require supplemental dose after dialysis.²¹¹

Fixed-combination captopril/hydrochlorothiazide tablets usually are not recommended for patients with severe renal impairment.¹⁰²

Geriatric Patients

Hypertension

Usual adult dosages generally have been used; dosages of 6.25–12.5 mg 1–4 times daily used occasionally.¹⁷⁵

Volume-and/or Salt-Depleted Patients

Correct volume and/or salt depletion prior to initiation of therapy or initiate therapy under close medical supervision using lower initial dosage.¹¹⁵ ¹¹⁶ ¹⁴⁸ ¹⁵³ (See Dosage: CHF, under Dosage and Administration.)

Cautions for Capoten

Contraindications

Known hypersensitivity (e.g. history of angioedema) to captopril or another ACE inhibitor.¹¹⁵ ¹⁴⁷ ³²⁵ ³²⁶ ³³³

Warnings/Precautions

Warnings

Hematologic Effects

Possible neutropenia or agranulocytosis; risk of neutropenia appears to depend principally on degree of renal impairment and presence of collagen vascular disease (e.g., systemic lupus erythematosus, scleroderma).¹¹⁵

Use with caution and only after careful risk/benefit assessment in patients with collagen vascular disease or those taking drugs known to affect leukocytes or immune response.¹¹⁵

If used in patients with renal impairment, determine complete and differential leukocyte counts prior to initiation of therapy, at about 2-week intervals for the first 3 months of therapy, and periodically thereafter.¹¹⁵ Discontinue therapy if confirmed neutrophil count is <1000/mm³.¹¹⁵

Proteinuria

Proteinuria possible, particularly in patients with prior renal disease and/or those receiving relatively high dosages (>150 mg daily).¹¹⁵ Usually occurs by the 8th month of treatment¹ ³ ⁴⁶ and subsides or clears within 6 months whether or not therapy is continued;¹¹⁵ however, may persist in some patients.^a

Hypotension

Possible excessive hypotension, particularly in volume- and/or salt-depleted patients (e.g., those treated with diuretics or undergoing dialysis, patients with severe CHF).¹ ⁵ ¹⁷ ²³ ²⁵ ³¹ ⁶⁶ ⁸⁵ ¹¹⁵ ¹¹⁶ ¹⁴⁸ ¹⁵⁴ ¹⁵⁶

Hypotension may occur in patients undergoing surgery or during anesthesia with agents that produce hypotension; recommended treatment is fluid volume expansion.¹¹⁵

Transient hypotension is not a contraindication to additional doses; may reinstate therapy cautiously after BP is stabilized (e.g., with volume expansion).¹¹⁵

To minimize potential for hypotension, consider recent antihypertensive therapy, extent of BP elevation, sodium intake, fluid status, and other clinical conditions.^a (See Special Populations under Dosage and Administration.) Discontinue other antihypertensive therapy, if possible, 1 week before initiating captopril, except in patients with severe hypertension.¹¹⁵ ^a Withholding diuretic therapy and/or increasing sodium intake approximately 3–7 days prior to initiation of captopril may minimize potential for severe hypotension.¹¹⁵ ¹¹⁶ ¹⁴⁸ ¹⁵³

Initiate therapy in patients with CHF under close medical supervision; monitor closely for first 2 weeks following initiation of captopril or any increase in captopril or diuretic dosage.¹¹⁵

Fetal/Neonatal Morbidity and Mortality

Possible fetal and neonatal morbidity and mortality when used during pregnancy.¹⁰² ¹¹⁵ ²³⁹ ²⁴⁰ ²⁴¹ ⁴⁰² (See Boxed Warning.) Such potential risks occur throughout pregnancy, especially during the second and third trimesters.⁴⁰²

Also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.⁴⁰¹ ⁴⁰²

Discontinue as soon as possible when pregnancy is detected, unless continued use is considered lifesaving.⁴⁰² Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy.²³⁹

Hepatic Effects

Clinical syndrome that usually is manifested initially by cholestatic jaundice and may progress to fulminant hepatic necrosis (occasionally fatal) reported rarely with ACE inhibitors.¹⁰² ¹¹⁵ ³⁷⁰

If jaundice or marked elevation of liver enzymes occurs, discontinue drug and monitor patient.¹¹⁵

Sensitivity Reactions

Anaphylactoid reactions and/or angioedema possible; if associated with laryngeal edema, may be fatal.¹¹⁵ ³³³ Immediate medical intervention (e.g., epinephrine) for involvement of tongue, glottis, or larynx.¹¹⁵ Intestinal angioedema possible; consider in differential diagnosis of patients who develop abdominal pain.¹¹⁵

Anaphylactoid reactions reported in patients receiving ACE inhibitors while undergoing LDL apheresis with dextran sulfate absorption¹¹⁵ ²⁷⁵ ²⁷⁶ ²⁷⁷ or following initiation of hemodialysis that utilized high-flux membrane.¹⁰² ¹¹⁵ ²⁴² ²⁴³ ²⁴⁴

Life-threatening anaphylactoid reactions reported in at least 2 patients receiving ACE inhibitors while undergoing desensitization treatment with hymenoptera venom.¹⁰² ¹⁵⁵ ²⁷⁸

Not recommended in patients with a history of angioedema associated with or unrelated to ACE inhibitors.^a

General Precautions

Renal Effects

Transient increases in BUN and S_cr possible, especially in patients with preexisting renal impairment, sodium depletion, or hypovolemia; patients with renovascular hypertension, particularly those with bilateral renal-artery stenosis or those with renal-artery stenosis in a solitary kidney;⁵ ⁸⁶ ¹¹⁵ ¹¹⁷ ¹²² ¹²³ ¹²⁴ ²⁰⁷ ²⁰⁸ ²⁰⁹ ³³³ ³⁷² or patients with chronic or severe hypertension in whom the glomerular filtration rate may decrease transiently.¹ ¹¹⁵

Possible increases in BUN and S_cr in patients with CHF;¹¹⁵ ²⁰⁶ ³³³ rapidity of onset and magnitude may depend in part on degree of sodium depletion.¹⁴⁸ ¹⁵⁶ ²⁰⁶ ³⁷²

Closely monitor renal function following initiation of therapy in such patients.⁸⁶ ⁸⁷ ¹¹⁵ ¹¹⁷ ¹²² ¹²³ ¹²⁴ ³³³ ³⁷² Some patients may require dosage reduction or discontinuance of ACE inhibitor or diuretic and/or adequate sodium repletion.¹¹⁵ ¹⁵⁶ ²⁰⁶ ²⁰⁷ ²⁰⁹

Hyperkalemia

Possible hyperkalemia,⁵ ⁷ ³⁸ ⁶⁹ ⁷⁰ ⁸⁵ ¹¹⁵ ¹²² ¹²⁵ ¹²⁶ ¹⁶² ¹⁶³ ¹⁶⁴ ¹⁷⁷ especially in patients with impaired renal function, CHF, or diabetes mellitus and those receiving drugs that can increase serum potassium concentration (e.g., potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes).³⁸ ⁸⁵ ¹¹⁵ ¹²⁵ ¹²⁶ ¹⁴⁸ ¹⁶² ¹⁶³ ¹⁶⁴ ³³³ ³⁷² (See Interactions.)

Monitor serum potassium concentration carefully in these patients.¹²⁶ ¹⁶² ¹⁶³

Cough

Persistent and nonproductive cough; resolves after drug discontinuance.¹⁰² ¹¹⁵ ³³³

Valvular Stenosis

Possible risk of decreased coronary perfusion in patients with aortic stenosis when treated with captopril.^a ¹¹⁵

Use of Fixed Combinations

When used in fixed combination with hydrochlorothiazide, consider the cautions, precautions, and contraindications associated with hydrochlorothiazide.¹⁰²

Specific Populations

Pregnancy

Category C (1st trimester); Category D (2nd and 3rd trimesters).¹¹⁵ (See Fetal/Neonatal Morbidity and Mortality under Cautions and see Boxed Warning.)

Lactation

Distributed into milk.¹¹⁵ Discontinue nursing or the drug.¹¹⁵

Pediatric Use

Safety and efficacy not established; however, captopril has been used in children.¹¹⁵ Manufacturer states that captopril should be used only when other measures for controlling BP have not been effective.¹¹⁵

Possible excessive, prolonged, and unpredictable decreases in BP and associated complications (e.g., oliguria, seizures) in infants.¹¹⁵

Renal Impairment

Systemic exposure to captopril may be increased.¹¹⁵ (See Special Populations under Pharmacokinetics.) Initial dosage adjustment recommended in patients with severe renal impairment.¹¹⁵ (See Renal Impairment under Dosage and Administration.)

Deterioration of renal function may occur.¹¹⁵ ²¹¹ Possible increased risk of neutropenia/agranulocytosis,¹¹⁵ proteinuria,¹¹⁵ and hyperkalemia.¹¹⁵ (See Warnings and General Precautions under Cautions.)

Use of captopril/hydrochlorothiazide fixed combination usually is not recommended in patients with severe renal impairment.¹⁰²

Blacks

BP reduction may be smaller in black patients compared with nonblack patients;¹¹⁵ ¹³⁹ ¹⁷⁷ ¹⁷⁸ ¹⁷⁹ ¹⁸⁰ ¹⁸¹ ³⁵¹ however, no apparent population difference during combined therapy with ACE inhibitor and thiazide diuretic.¹⁷⁹ ¹⁹³ ¹⁹⁴ ²¹⁷ ²¹⁸ ²¹⁹ ³¹⁶ Use in combination with a diuretic.¹⁷⁹ ¹⁹³ ¹⁹⁴ ²¹⁷ ²¹⁸ ²¹⁹ ³¹⁶

Higher incidence of angioedema reported with ACE inhibitors in blacks compared with other races.¹⁰² ¹¹⁵ ³²⁵ ³²⁶ ³²⁷ ³⁵¹ ³⁷⁹ ³⁸⁰

Common Adverse Effects

Rash, pruritus, cough, dysgeusia, proteinuria, tachycardia, chest pain, palpitations.¹¹⁵

Interactions for Capoten

Specific Drugs and Laboratory Tests

Drug	Interaction	Comments
Adrenergic neuron blocking agents (guanethidine)	Possible increased hypotensive effect¹¹⁵	Use with caution¹¹⁵
Antacids	Decreased rate and extent of captopril absorption¹⁹⁷ ²⁰¹	Clinical importance is uncertain¹⁹⁷ ²⁰¹
Antidiabetic agents, oral	Possible hypoglycemia in diabetic patients¹⁰¹	Consider risk of hypoglycemia if used concomitantly¹⁰¹
Allopurinol	Pharmacokinetic interaction unlikely¹¹⁵
β-adrenergic blocking agents	Increased (but less than additive) hypotensive effect¹¹⁵
Cimetidine	Neuropathy reported^a	Further documentation of interaction necessary^a
Digoxin	Possible increased serum digoxin concentrations in patients with CHF¹⁹⁸ ¹⁹⁹ ²⁰⁰	Monitor serum digoxin concentration;¹⁹⁸ ²⁰⁰ reduction of digoxin dosage not required upon initiation of captopril¹⁹⁸
Diuretics	Possible additive hypotensive effects^a Pharmacokinetic interaction with furosemide unlikely¹¹⁵	Adjust dosage carefully^a (see Dosage under Dosage and Administration)
Diuretics, potassium-sparing (amiloride, spironolactone, triamterene)	Possible hyperkalemia, especially in patients with renal impairment¹⁶² ³²⁹ ³³¹ ³³⁵	Use cautiously and only if hypokalemia is documented; monitor serum potassium carefully;⁸⁵ ¹¹⁵ ¹²⁵ ¹²⁶ ¹⁴⁸ ¹⁶² ¹⁶³ ¹⁶⁴ discontinue or reduce dosage of potassium-sparing diuretic as necessary⁸⁵ ¹²⁶ ¹⁴⁸ ¹⁶² ¹⁶³
Insulin	Possible hypoglycemia in diabetic patients¹⁰¹	Consider risk of hypoglycemia¹⁰¹
Lithium	Possible increased serum lithium concentrations, particularly in patients receiving concomitant diuretic therapy¹¹⁵	Use with caution; monitor serum lithium concentrations frequently¹¹⁵
NSAIAs	Possible decreased antihypertensive response to captopril;²⁸³ ²⁸⁴ ²⁸⁵ ²⁸⁶ ²⁸⁷ ²⁸⁸ ²⁸⁹ ²⁹⁰ ³³³ ³⁶⁴ potential for acute reduction of renal function;²⁸⁵ ²⁹¹ possible attenuation of hemodynamic actions of ACE inhibitors in patients with CHF³³³ ³⁶⁴	Monitor BP carefully and be alert for evidence of impaired renal function;²⁸⁵ if interaction is suspected, discontinue NSAIA or modify captopril dosage or use another hypotensive agent²⁸⁵ ²⁸⁶
Potassium supplements or potassium-containing salt substitutes	Possible hyperkalemia, especially in patients with renal impairment¹⁶²	Use cautiously and only if hypokalemia is documented; monitor serum potassium carefully;⁸⁵ ¹¹⁵ ¹²⁵ ¹²⁶ ¹⁴⁸ ¹⁶² ¹⁶³ ¹⁶⁴ discontinue or reduce dosage of potassium supplement as necessary⁸⁵ ¹²⁶ ¹⁴⁸ ¹⁶² ¹⁶³
Probenecid	Possible increased blood concentrations of captopril and its metabolites²⁰³ ²⁰⁴ ²⁰⁵ ²¹³
Test for urine acetone	Possible false-positive results with sodium nitroprusside reagent⁵⁴ ¹¹⁵
Vasodilating agents (e.g., hydralazine, nitrates, prazosin)	Possible increased hypotensive effect¹¹⁵	If possible, discontinue vasodilating agent before starting captopril; if vasodilating agent is resumed during captopril therapy, administer with caution and possibly at a lower dosage¹¹⁵

Capoten Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed following oral administration in fasting individuals,¹⁹ ²⁰ ⁸⁴ ¹¹⁵ with peak blood concentration attained in 1 hour.¹⁹ Approximately 60–75% of an oral dose is absorbed.¹⁹ ²⁰ ⁸⁴ ¹¹⁵

Onset

Hypotensive effect may be apparent within 15 minutes⁵ ⁶ ¹⁶ ²³ and usually is maximal in 1–2 hours after a single oral dose.¹ ³ ¹⁰ ¹⁵ ¹⁶ ¹⁷ ²¹ ²⁴ ²⁹ Several weeks of therapy may be required before full effect on BP is achieved.¹ ³ ⁵ ¹⁶ ²¹ ²⁸

Duration

Duration of action generally is 2–6 hours but appears to increase with increasing doses.^a

Food

Food may decrease absorption of captopril by up to 25–40%;¹ ³ ¹¹⁵ ¹⁹¹ ¹⁹⁵ ¹⁹⁶ ¹⁹⁷ ²⁰² effect may not be clinically important.¹⁹¹ ¹⁹² ¹⁹⁵

Distribution

Extent

Appears to be rapidly distributed into most body tissues, except CNS.¹ ⁵

Crosses the placenta and is distributed into milk.¹¹⁵

Plasma Protein Binding

25–30%¹ ³ ²² (mainly albumin).³

Elimination

Metabolism

About half the absorbed dose is rapidly metabolized.³ ⁵ ¹⁹ Captopril and its metabolites may undergo reversible interconversions.³

Elimination Route

Excreted in urine (95%) as unchanged drug (40–50%) and metabolites.³ ¹⁹ ²⁰ ²² ¹¹⁵

Half-life

<2 hours.¹¹⁵

Special Populations

Elimination half-life is about 20–40 hours in patients with Cl_cr <20 mL/minute ³ and up to 6.5 days in anuric patients.⁵ ²²

Stability

Storage

Oral

Tablets

Tight containers at ≤30°C.¹¹⁵

Tablets (Captopril and Hydrochlorothiazide)

Tight containers at ≤30°C.¹⁰²

ActionsActions

Suppresses the renin-angiotensin-aldosterone system.¹

Advice to Patients

Risk of angioedema, anaphylactoid reactions, or other sensitivity reactions.¹¹⁵ Importance of reporting sensitivity reactions (e.g., edema of face, eyes, lips, tongue, or extremities; hoarseness; swallowing or breathing with difficulty) immediately to clinician and of discontinuing the drug.¹¹⁵

Importance of reporting signs of infection (e.g., sore throat, fever).¹¹⁵

Risk of hypotension.¹¹⁵ Importance of informing clinicians promptly if lightheadedness or fainting occurs.¹¹⁵

Importance of adequate fluid intake; risk of volume depletion with excessive perspiration, dehydration, vomiting, or diarrhea.¹¹⁵

Importance of not discontinuing or interrupting therapy unless instructed by a clinician.¹¹⁵

Risks of use during pregnancy.¹¹⁵ ⁴⁰¹ ⁴⁰² (See Boxed Warning.)

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs (including salt substitutes containing potassium) as well as any concomitant illnesses.¹¹⁵

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹¹⁵

Importance of taking 1 hour before meals.¹¹⁵

Importance of advising patients of other important precautionary information.¹¹⁵ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Captopril
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	12.5 mg*	Capoten (scored)	Par
		25 mg*	Capoten (scored)	Par
		50 mg*	Capoten (scored)	Par
		100 mg*	Capoten (scored)	Par

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Captopril and Hydrochlorothiazide
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	25 mg Captopril and Hydrochlorothiazide 15 mg*	Capozide (scored)	Par
			Captopril and Hydrochlorothiazide Tablets	Endo, Mylan, Sandoz, Teva
		25 mg Captopril and Hydrochlorothiazide 25 mg*	Capozide (scored)	Par
			Captopril and Hydrochlorothiazide Tablets	Endo, Mylan, Sandoz, Teva
		50 mg Captopril and Hydrochlorothiazide 15 mg*	Capozide (scored)	Par
			Captopril and Hydrochlorothiazide Tablets	Endo, Mylan, Sandoz, Teva
		50 mg Captopril and Hydrochlorothiazide 25 mg*	Capozide (scored)	Par
			Captopril and Hydrochlorothiazide Tablets	Endo, Mylan, Sandoz, Teva

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Capozide 50-25MG Tablets (PAR): 30/$95.99 or 90/$269.98

Captopril 100MG Tablets (WEST-WARD): 90/$19.99 or 180/$29.97

Captopril 12.5MG Tablets (WEST-WARD): 100/$12.99 or 200/$18.98

Captopril 25MG Tablets (TEVA PHARMACEUTICALS USA): 90/$13.99 or 180/$26.99

Captopril 50MG Tablets (WEST-WARD): 100/$16.99 or 200/$22.97

Captopril-Hydrochlorothiazide 25-15MG Tablets (MYLAN): 90/$47.99 or 270/$114.97

Captopril-Hydrochlorothiazide 25-25MG Tablets (MYLAN): 90/$44.99 or 270/$125.99

Captopril-Hydrochlorothiazide 50-15MG Tablets (TEVA PHARMACEUTICALS USA): 60/$53.99 or 180/$154.98

Captopril-Hydrochlorothiazide 50-25MG Tablets (MYLAN): 60/$53.99 or 180/$154.99

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. ER Squibb & Sons, Inc. Capoten prescribing information. Princeton, NJ; 1981 Mar.

3. ER Squibb & Sons, Inc. Capoten (captopril) monograph. Princeton, NJ; 1981 Apr.

4. Atkinson AB, Robertson JIS. Captopril in the treatment of clinical hypertension and cardiac failure. Lancet. 1979; 2:836-9. [IDIS 102581] [PubMed 90928]

5. Heel RC, Brogden RN, Speight TM et al. Captopril: a preliminary review of its pharmacological properties and therapeutic efficacy. Drugs. 1980; 20:409-52. [IDIS 134943] [PubMed 7009133]

6. Ferguson RK, Turini GA, Brunner HR et al. A specific orally active inhibitor of angiotensin-converting enzyme in man. Lancet. 1977; 1:775-8. [IDIS 78256] [PubMed 66571]

7. Gavras H, Brunner HR, Turini GA et al. Antihypertensive effect of the oral angiotensin converting-enzyme inhibitor SQ 14225 in man. N Engl J Med. 1978; 298:991-5. [IDIS 80115] [PubMed 205788]

8. Larochelle P, Genest J, Kuchel O et al. Effect of captopril (SQ 14225) on blood pressure, plasma renin activity and angiotensin I converting enzyme activity. Can Med Assoc J. 1979; 121:309-16. [IDIS 100999] [PubMed 223756]

9. Swartz S, Williams GH, Hollenberg NK et al. Increase in prostaglandins during converting enzyme inhibition. Clin Sci. 1980; 59(Suppl):133-5S.

10. Brunner HR, Gavras H, Waeber B et al. Oral angiotensin-converting enzyme inhibitor in long-term treatment of hypertensive patients. Ann Intern Med. 1979; 90:19-23. [IDIS 96700] [PubMed 217289]

11. Johnston CI, Millar JA, McGrath BP et al. Long-term effects of captopril (SQ 14225) on blood-pressure and hormone levels in essential hypertension. Lancet. 1979; 2:493-6. [IDIS 103099] [PubMed 90216]

12. McCaa CS, Langford HG, Cushman WC et al. Response of arterial blood pressure, plasma renin activity and aldosterone concentration to long-term administration of captopril to patients with severe, treatment-resistant malignant hypertension. Clin Sci. 1979; 57(Suppl):371-3S.

13. Fagard R, Amery A, Reybrouck T et al. Acute and chronic systemic and pulmonary hemodynamic effects of angiotensin converting enzyme inhibition with captopril in hypertensive patients. Am J Cardiol. 1980; 46:295-300. [IDIS 122485] [PubMed 6250392]

14. Maruyama A, Ogihara T, Naka T et al. Long-term effects of captopril in hypertension. Clin Pharmacol Ther. 1980; 28:316-23. [IDIS 123828] [PubMed 6996895]

15. Mimran A, Brunner HR, Turini GA et al. Effect of captopril on renal vascular tone in patients with essential hypertension. Clin Sci. 1979; 57(Suppl):421-3S. [IDIS 109948] [PubMed 519950]

16. Case DB, Atlas SA, Laragh JH et al. Clinical experience with blockade of the renin-angiotensin-aldosterone system by an oral converting-enzyme inhibitor (SQ 14,225, captopril) in hypertensive patients. Prog Cardiovasc Dis. 1978; 21:195-206. [PubMed 214819]

17. Morganti A, Pickering TG, Lopez-Ovejero JA et al. Endocrine and cardiovascular influences of converting enzyme inhibition with SQ 14225 in hypertensive patients in the supine position and during head-up tilt before and after sodium depletion. J Clin Endocrinol Metab. 1980; 50:748-54. [IDIS 124889] [PubMed 6245101]

19. Kripalani KJ, McKinstry DN, Singhvi SM et al. Disposition of captopril in normal subjects. Clin Pharmacol Ther. 1980; 27:636-41. [IDIS 113124] [PubMed 6989546]

20. McKinstry DN, Kripalani KJ, Migdalof BH et al. The effect of repeated administration of captopril (CP) on its disposition in hypertensive patients. Clin Pharmacol Ther. 1980; 27:270-1.

21. Case DB, Atlas SA, Laragh JH et al. Use of