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MINT-ACYCLOVIR is a brand name for Acyclovir, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS ................................................................................................. 4 WARNINGS AND…
Verbatim from this product's HC label. Tap a section to expand.
MINT-ACYCLOVIR (Acyclovir Tablets USP) is contraindicated for patients who develop hypersensitivity or who are hypersensitive to acyclovir, valacyclovir or any other components of the formulations of MINT-ACYCLOVIR. For a complete listing, see DOSAGE FORMS, COMPOSITION AND PACKAGING section of the product monograph.
WARNINGS AND PRECAUTIONS General Care should be taken to maintain adequate hydration in patients receiving high oral doses of acyclovir. Suppressive therapy of herpes genitalis with acyclovir should be considered only for severely affected patients.
Periodic evaluation of the need for continued suppressive therapy is recommended. In some patients, there is a tendency for the first recurrent episode to be more severe following cessation of suppressive therapy. In severely immunocompromised patients, the physician should be aware that prolonged or repeated courses of acyclovir may result in selection of resistant viruses associated with infections which may not respond.
Thrombotic thrombocytopenic purpura/haemolytic uremic syndrome (TTP/HUS), which has resulted in death, has occurred in immunocompromised patients receiving acyclovir therapy. The recommended dosage and length of treatment should not be exceeded (see DOSAGE AND ADMINISTRATION).
The decision to prescribe a course of suppressive therapy should be weighed in the light of our present knowledge about the long-term effects of acyclovir and must clearly relate to the condition of the patient. Whereas cutaneous lesions associated with herpes simplex infections are often pathognomonic, Tzanck smears prepared from lesion exudate or scrapings may assist in the diagnosis.
Positive cultures for herpes simplex virus offer the only absolute means for confirmation of the diagnosis. Appropriate examinations should be performed to rule out other sexually transmitted diseases. All patients should be advised to take particular care to avoid potential transmission of virus if active lesions are present while they are on therapy.
Genital herpes can also be transmitted in the absence of symptoms through asymptomatic viral shedding. The clinical status of the patient and the adverse event profile of acyclovir should be borne in mind when considering the patient’s ability to drive or operate machinery.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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There have been no studies to investigate the effect of acyclovir on driving performance or the ability to operate machinery. Further, a detrimental effect on such activities cannot be predicted from the pharmacology of the active substance.
Carcinogenesis and Mutagenesis MINT-ACYCLOVIR Product Monograph Page 5 of 37 Acyclovir has caused mutagenesis in some acute studies at high concentrations of the drug (see Part II, TOXICOLOGY). Renal Renal insufficiency or acute renal failure has been observed in patients taking acyclovir at the recommended dosage and/or with no previous renal conditions and may be associated with renal pain (see ADVERSE REACTIONS, Post-Market Adverse Drug Reactions).
Acyclovir is eliminated by renal clearance, therefore the dose must be reduced in patients with renal impairment (see DOSAGE AND ADMINISTRATION, Patients with Acute or Chronic Renal Impairment). Elderly patients are likely to have reduced renal function and therefore the need for dose reduction must be considered in this group of patients.
Both elderly patients and patients with renal impairment are at increased risk of developing neurological side effects and should be closely monitored for evidence of these effects. In the reported cases, these reactions were generally reversible on discontinuation of treatment (see ADVERSE REACTIONS).
Caution should be exercised when administering to patients receiving potentially nephrotoxic agents since this may increase the risk of renal dysfunction. Sexual Function/Reproduction In a study of 20 male patients with normal sperm count, oral acyclovir administered at doses of up to 1 g per day for up to six months has been shown to have no clinically significant effect on sperm count, motility or morphology.
There is no information on the effect of acyclovir oral formulations on human female fertility. Special Populations Pregnant Women Teratology studies carried out to date in animals have been negative in general. However, in a non-standard test in rats, there were fetal abnormalities such as head and tail anomalies, and maternal toxicity; since such studies are not always predictive of human response, acyclovir should not be used during pregnancy unless the physician feels the potential benefit justifies the risk of possible harm to the fetus.
The potential for high concentrations of acyclovir to cause chromosome breaks in vitro should be taken into consideration in making this decision. A post-marketing acyclovir pregnancy registry has documented pregnancy outcomes in women exposed to any formulation of acyclovir.
The registry findings have not shown an increase in the number of birth defects amongst subjects exposed to acyclovir compared with the general population, and any birth defects showed no uniqueness or consistent pattern to suggest a common cause.
1 times corresponding plasma levels. 3 mg/kg MINT-ACYCLOVIR Product Monograph Page 6 of 37 per day. Caution should therefore be exercised when acyclovir is administered to a nursing woman. Pediatrics Safety and effectiveness in children less than 2 years of age have not been adequately studied.
Geriatrics The possibility of renal impairment in the elderly must be considered and the dosage should be adjusted accordingly (see WARNINGS AND PRECAUTIONS, Renal, and DOSAGE AND ADMINISTRATION, Patients with Acute or Chronic Renal Impairment).
Adequate hydration of elderly patients taking high oral doses of acyclovir should […]