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Acycloriv ®

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Indications:

Herpes Zoster: is indicated for the treatment of herpes zoster (shingles). Genital Herpes: is indicated for the treatment or suppression of genital herpes in immunocompetent individuals and for the suppression of recurrent genital herpes in HIV-infected individuals. When used as suppressive therapy in immunocompetent individuals with genital herpes, the risk of heterosexual transmission to susceptible partners is reduced. Safer sex practices should be used with suppressive therapy. Cold Sores (Herpes Labialis): is indicated for the treatment of cold sores (herpes labialis).

Contraindications:

contraindicated in patients with a known hypersensitivity or intolerance to valacyclovir, acyclovir, or any component of the formulation. WARNINGS: Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), in some cases resulting in death, has occurred in patients with advanced HIV disease and also in allogeneic bone marrow transplant and renal transplant recipients participating in clinical trials of valacyclovir at doses of 8 grams per day.

Adverse reactions:

General: Facial edema, hypertension, tachycardia. Allergic: Acute hypersensitivity reactions including anaphylaxis, angioedema, dyspnea, pruritus, rash, and urticaria. CNS Symptoms: Aggressive behavior; agitation; ataxia; coma; confusion; decreased consciousness; dysarthria; encephalopathy; mania; and psychosis, including auditory and visual hallucinations; seizures, tremors. Eye: Visual abnormalities. Gastrointestinal: Diarrhea. Hepatobiliary Tract and Pancreas: Liver enzyme abnormalities, hepatitis. Renal: Elevated creatinine, renal failure. Hematologic: Thrombocytopenia, aplastic anemia, leukocytoclastic vasculitis. Skin: Erythema multiforme, rashes including photosensitivity, alopecia. Renal Impairment: Renal failure and CNS symptoms have been reported in patients with renal impairment who received valacyclovir or acyclovir at greater than the recommended dose.

Interactions:

The pharmacokinetics of digoxin was not affected by coadministration of EXONELLA 1 gram 3 times daily, and the pharmacokinetics of acyclovir after a single dose of EXONELLA (1 gram) was unchanged by coadministration of digoxin (2 doses of 0.75 mg), single doses of antacids (Al 3+ or Mg ++ ), or multiple doses of thiazide diuretics. Acyclovir C max and AUC following a single dose of EXONELLA (1 gram) increased by 8% and 32%, respectively, after a single dose of cimetidine (800 mg), or by 22% and 49%, respectively, after probenecid (1 gram), or by 30% and 78%, respectively, after a combination of cimetidine and probenecid, primarily due to a reduction in renal clearance of acyclovir. These effects are not considered to be of clinical significance in subjects with normal renal function. Therefore, no dosage adjustment is recommended when Acyclovir is coadministered with digoxin, antacids, thiazide diuretics, cimetidine, or probenecid in subjects with normal renal function.

Warnings:

Dosage reduction is recommended when administering Acyclovir to patients with renal impairment. Similar caution should be exercised when administering Acyclovir to geriatric patients and patients receiving potentially nephrotoxic agents. Given the dosage recommendations for treatment of cold sores, special attention should be paid when prescribing Acyclovir for cold sores in patients who are elderly or who have impaired renal function. Treatment should not exceed 1 day (2 doses of 2 grams in 24 hours). Therapy beyond 1 day does not provide additional clinical benefit. Precipitation of acyclovir in renal tubules may occur when the solubility (2.5 mg/mL) is exceeded in the intratubular fluid. In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored. The safety and efficacy of Acyclovir have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients. The safety and efficacy of Acyclovir for suppression of recurrent genital herpes in patients with advanced HIV disease have not been established. The efficacy of Acyclovir for the treatment of genital herpes in HIV-infected patients has not been established. The safety and efficacy of Acyclovir have not been established for the treatment of disseminated herpes zoster. The efficacy of Acyclovir for reducing transmission of genital herpes has not been established in individuals with multiple partners and non-heterosexual couples.

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Dr. Samer Al-Jneidy

Dr. Samer Al-Jneidy Pediatrician

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