Ralmac — Raltegravir 400 mg Tablets, 60 Tabs

Ralmac-400 is manufactured in film-coated tablet form:

• Dosage Form & Packaging: 1 plastic bottle contains 60 tablets, packed in a cardboard box.
• Active Ingredient: Raltegravir potassium, equivalent to Raltegravir — 400 mg per tablet.
• Excipients: Lactose monohydrate, microcrystalline cellulose, dibasic calcium phosphate, poloxamer 407, sodium stearyl fumarate, magnesium stearate, Opadry coating.

Pharmacodynamics: Raltegravir inhibits the catalytic activity of HIV integrase, an enzyme required for retroviral replication (including FeLV/FIV). Blocking integrase prevents integration of proviral DNA into the host cell genome, effectively stopping viral replication and systemic spread.

Pharmacokinetics: Rapidly absorbed following oral administration. Metabolized primarily in the liver via glucuronidation (UGT1A1). Excreted in feces and urine.

Ralmac-400 is indicated for:

• 🔹 Human Medical Use: Treatment of HIV-1 infection in adults, adolescents, and children in combination with other antiretroviral agents.
• 🔹 Veterinary Use (Off-label): Management of retroviral infections in cats — Feline Leukemia Virus (FeLV) and Feline Immunodeficiency Virus (FIV) to reduce viral burden.

Administration guidelines for Ralmac-400:

• 👤 For Humans: Standard dose is 400 mg (1 tablet) twice daily. Swallow whole with water, with or without food.
• 🐾 For Cats (Veterinary Protocol): Dosing is tailored individually by a veterinarian (typically 20 mg to 40 mg per cat twice daily based on body weight and protocol). Tablets are split accordingly. Administered long-term with routine CBC and biochemistry monitoring.

Ralmac-400 is contraindicated in:

• ❌ Hypersensitivity to raltegravir or excipients.
• ❌ Severe hepatic impairment.
• ❌ Pediatric patients weighing less than 25 kg (for this 400 mg tablet formulation).
• ❌ Pregnancy and lactation unless clinically necessary. Use with caution in breeding animals.

Consider the following drug interactions for Ralmac-400:

• ⚠️ Antacids: Co-administration with aluminum or magnesium-containing antacids is contraindicated due to significant reduction in raltegravir absorption.
• ⚠️ UGT1A1 Inducers: Strong inducers like rifampin decrease raltegravir plasma levels (dose adjustment required).
• ⚠️ Veterinary Context: Compatible with supportive care drugs, liver supplements, and antibiotics without antacid interactions.

Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. HIV-infected mothers should not breastfeed. Not recommended for pregnant or lactating animals.

Potential side effects of Ralmac-400:

• 🤢 In Humans: Nausea, headache, insomnia, diarrhea, fatigue, rash.
• 🐾 In Cats: Transient hyporexia, nausea, mild diarrhea, rare liver enzyme elevations or anemia during prolonged therapy.

Symptoms: Exacerbation of gastrointestinal distress and dizziness.

Treatment: No specific antidote. Administer gastric lavage if recent, activated charcoal, and supportive treatment.

Storage instructions for Ralmac-400:

• 🌡️ Temperature: Store in a dry place between 15 °C and 30 °C.
• 💧 Moisture: Keep bottle tightly closed in its original box.
• 👶 Safety: Keep out of reach of children and pets.

Authenticity features of original Ralmac-400:

• 🛡️ Branding & Logo: Official blue and pink MA (McNeil & Argus) logo on carton and bottle label. Distinct vertical red bar on the left edge.
• 🔍 Batch Markings: Clearly printed Batch No., Mfg. Date, Expiry Date, M.R.P., and barcode on bottle label and box. Product name Ralmac-400 in pink typography.
• 📦 Packaging: White plastic bottle with ribbed safety cap containing exactly 60 tablets.