Cyclophosphamide 25mg tablet

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it. How should I use this medication? The recommended dose of cyclophosphamide varies widely according to the specific condition being treated, the response to therapy, and other medications being used.

The dose is based on body weight. It is available as an intravenous into the vein injection and as an oral tablet. The intravenous form is injected into a specially prepared site on the skin. The dosing regimen for this medication varies widely.

Tablets are sometimes taken on a daily basis in smaller doses, but can also be given in larger doses for a few days at a time with 2- to 4-week intervals between doses.

The intravenous form of the medication is sometimes administered twice a week, but larger doses may be given every 3 to 4 weeks depending on the condition being treated. The intravenous form of cyclophosphamide is always given under the supervision of a doctor. Very careful handling of this medication is required. It is always given in a hospital or similar setting with access to sterile equipment for preparation. Male patients who are sexually active with female partners who are or may become pregnant should use a condom during and for at least 4 months after treatment.

Infertility Females Amenorrhea, transient or permanent, associated with decreased estrogen and increased gonadotropin secretion develops in a proportion of women treated with cyclophosphamide. Affected patients generally resume regular menses within a few months after cessation of therapy.

The risk of premature menopause with cyclophosphamide increases with age. Oligomenorrhea has also been reported in association with cyclophosphamide treatment. The exact duration of follicular development in humans is not known, but may be longer than 12 months.

Males Men treated with cyclophosphamide may develop oligospermia or azoospermia which are normally associated with increased gonadotropin but normal testosterone secretion. Use in Patients with Renal Impairment In patients with severe renal impairment, decreased renal excretion may result in increased plasma levels of cyclophosphamide and its metabolites.

This may result in increased toxicity. Cyclophosphamide and its metabolites are dialyzable although there are probably quantitative differences depending upon the dialysis system being used. In patients requiring dialysis, use of a consistent interval between cyclophosphamide administration and dialysis should be considered. Use in Patients with Hepatic Impairment Patients with severe hepatic impairment have reduced conversion of cyclophosphamide to the active 4-hydroxyl metabolite, potentially reducing efficacy.

Overdosage should be managed with supportive measures, including appropriate treatment for any concurrent infection, myelosuppression, or cardiac toxicity should it occur. Serious consequences of overdosage include manifestations of dose dependent toxicities such as myelosuppression, urotoxicity, cardiotoxicity including cardiac failure , veno-occlusive hepatic disease, and stomatitis. Patients who received an overdose should be closely monitored for the development of toxicities, and hematologic toxicity in particular.

Cyclophosphamide and its metabolites are dialyzable. Therefore, rapid hemodialysis is indicated when treating any suicidal or accidental overdose or intoxication. Cystitis prophylaxis with mesna may be helpful in preventing or limiting urotoxic effects with cyclophosphamide overdose. The chemical name for cyclophosphamide is 2-[bis 2-chloroethyl amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula: Cyclophosphamide is soluble in water, saline, or ethanol.

Each capsule for oral administration contains 25 mg or 50 mg cyclophosphamide anhydrous, USP and the following inactive ingredients: In addition to the ingredients listed above, each capsule contains Opacode Black monogramming ink.

Opacode Black contains ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, and shellac.

Pharmacodynamics Cyclophosphamide is biotransformed principally in the liver to active alkylating metabolites by a mixed function microsomal oxidase system.

These metabolites interfere with the growth of susceptible rapidly proliferating malignant cells. Pharmacokinetics are linear over the dose range used clinically.

When cyclophosphamide was administered at 4. Absorption After oral administration, peak concentrations of cyclophosphamide occurred at one hour. AUCiv ranged from 0. Volume of distribution approximates total body water 30 to 50 L. Metabolism The liver is the major site of cyclophosphamide activation. Cyclophosphamide is activated to form 4-hydroxycyclophosphamide, which is in equilibrium with its ring-open tautomer aldophosphamide.

Exposure to cyclophosphamide during pregnancy may cause fetal malformations, miscarriage, fetal growth retardation, and toxic effects in the newborn.

If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus. Human Data Malformations of the skeleton, palate , limbs and eyes as well as miscarriage have been reported after exposure to cyclophosphamide in the first trimester. Fetal growth retardation and toxic effects manifesting in the newborn, including leukopenia, anemia, pancytopenia , severe bone marrow hypoplasia , and gastroenteritis have been reported after exposure to cyclophosphamide.

Animal Data Administration of cyclophosphamide to pregnant mice, rats, rabbits and monkeys during the period of organogenesis at doses at or below the dose in patients based on body surface area resulted in various malformations, which included neural tube defects, limb and digit defects and other skeletal anomalies, cleft lip and palate, and reduced skeletal ossification. Nursing Mothers Cyclophosphamide is present in breast milk. Neutropenia, thrombocytopenia, low hemoglobin , and diarrhea have been reported in infants breast fed by women treated with cyclophosphamide.

Because of the potential for serious adverse reactions in nursing infants from cyclophosphamide, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use Pre-pubescent girls treated with cyclophosphamide generally develop secondary sexual characteristics normally and have regular menses. Ovarian fibrosis with apparently complete loss of germ cells after prolonged cyclophosphamide treatment in late pre-pubescence has been reported. Girls treated with cyclophosphamide who have retained ovarian function after completing treatment are at increased risk of developing premature menopause. Pre-pubescent boys treated with cyclophosphamide develop secondary sexual characteristics normally, but may have oligospermia or azoospermia and increased gonadotropin secretion.

Some degree of testicular atrophy may occur. Cyclophosphamide-induced azoospermia is reversible in some patients, though the reversibility may not occur for several years after cessation of therapy.

Geriatric Use There is insufficient data from clinical studies of cyclophosphamide available for patients 65 years of age and older to determine whether they respond differently than younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac functioning, and of concomitant disease or other drug therapy.

Females and Males of Reproductive Potential Contraception Pregnancy should be avoided during treatment with cyclophosphamide because of the risk of fetal harm [see Use in Specific Populations]. Female patients of reproductive potential should use highly effective contraception during and for up to 1 year after completion of treatment. Male patients who are sexually active with female partners who are or may become pregnant should use a condom during and for at least 4 months after treatment.

Infertility Females Amenorrhea , transient or permanent, associated with decreased estrogen and increased gonadotropin secretion develops in a proportion of women treated with cyclophosphamide. Affected patients generally resume regular menses within a few months after cessation of therapy. The risk of premature menopause with cyclophosphamide increases with age.

Oligomenorrhea has also been reported in association with cyclophosphamide treatment. The exact duration of follicular development in humans is not known, but may be longer than 12 months [see Nonclinical Toxicology]. Males Men treated with cyclophosphamide may develop oligospermia or azoospermia which are normally associated with increased gonadotropin but normal testosterone secretion.

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