Iversun 12 — Ivermectin 12 mg Dispersible Tablets, 10 Tablets

Iversun-12 is supplied in the form of dispersible oral tablets.

Qualitative and Quantitative Composition per Tablet:

• Active Ingredient: Ivermectin — 12 mg.
• Excipients: Microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, aspartame, flavorings, magnesium stearate, colloidal silicon dioxide.

Packaging and Presentation: White to off-white dispersible tablets. 10 tablets per aluminum blister strip. Blister strips are supplied individually or packaged in an outer carton (10 blisters x 10 tablets = 100 tablets total) displaying Iversun-12 (Ivermectin Dispersible Tablets 12 mg) alongside Sunrise Remedies corporate styling.

Pharmacodynamics:
Ivermectin selectively binds with high affinity to glutamate-gated chloride ion channels in invertebrate nerve and muscle cells. This increases membrane permeability to chloride ions, causing hyperpolarization of nerve/muscle cells, resulting in neuromuscular paralysis and death of the parasite. Ivermectin also interacts with GABA-gated channels. In mammals, it does not readily cross the blood-brain barrier, providing a high safety margin.

Pharmacokinetics:

• Absorption: Rapidly absorbed from the GI tract after oral administration. Peak plasma concentrations are achieved approximately 4 hours post-dose.
• Distribution: Highly plasma protein-bound (~93%). Distributes widely into body tissues but does not cross the blood-brain barrier under normal physiological conditions.
• Metabolism: Extensively metabolized in the liver mainly by CYP3A4 into demethylated and hydroxylated metabolites.
• Elimination: Plasma half-life ranges between 12 and 18 hours. Excreted almost exclusively in feces, with less than 1% excreted unchanged in urine.

Iversun-12 is indicated in adults and pediatric patients weighing more than 15 kg for:

• Strongyloidiasis: Intestinal infection caused by Strongyloidiasis stercoralis.
• Onchocerciasis: "River blindness" caused by Onchocerca volvulus.
• Lymphatic Filariasis: As part of combination treatment to eradicate microfilariae.
• Scabies: Including crusted (Norwegian) scabies when topical treatment is ineffective or inappropriate.
• Other Nematodiases: Ascariasis, enterobiasis, trichuriasis, hookworm infections (as part of antihelminthic therapy).

Iversun-12 is administered orally.

Administration Instructions: As these are dispersible tablets, they may be swallowed whole with water or first dispersed in a small amount of clean drinking water (~50–100 ml) and consumed immediately. Must be taken on an empty stomach (1 hour before or 2 hours after meals) with water.

Dosing Regimen:

• Strongyloidiasis: Recommended single dose is 200 mcg ivermectin per kg body weight (for an adult weighing 60–80 kg, typically 1 to 1.5 tablets of 12 mg).
• Onchocerciasis: Recommended single dose is 150 mcg per kg body weight every 6 to 12 months.
• Scabies: Recommended single dose is 200 mcg per kg body weight. A second dose after 8–14 days may be required in severe cases.

Administration of Iversun-12 is contraindicated in:

• Hypersensitivity: Known hypersensitivity to ivermectin or any tablet excipient.
• Body Weight / Age Limit: Children weighing less than 15 kg (safety not established).
• Blood-Brain Barrier Impairment: Central nervous system disorders associated with compromised BBB integrity (e.g., African trypanosomiasis, meningitis).
• Pregnancy and Lactation: Contraindicated during pregnancy and breastfeeding.

Evaluated drug interactions for Iversun include:

• GABAergic Agents: Co-administration with drugs enhancing GABA activity (barbiturates, benzodiazepines, valproic acid) may increase CNS depression risks.
• CYP3A4 Inhibitors/Inducers: Potent CYP3A4 inhibitors may increase ivermectin levels; inducers may decrease efficacy.
• Warfarin: Potential enhancement of anticoagulant effects; INR monitoring is recommended.

Pregnancy:
Iversun-12 is contraindicated during pregnancy. Safety in pregnant women has not been demonstrated. Teratogenic effects have been observed in animal studies at maternally toxic doses.

Lactation:
Ivermectin is excreted in human milk in low concentrations. Breastfeeding should be discontinued if treatment is required.

Adverse effects are generally mild and transient. In onchocerciasis patients, reactions are often linked to microfilarial death (Mazzotti reaction):

• Allergic/Immune Reactions (Mazzotti Reaction): Pruritus, rash, urticaria, fever, lymph node enlargement/tenderness, myalgia, arthralgia.
• Nervous System: Dizziness, somnolence, tremor, headache, postural hypotension.
• Gastrointestinal Tract: Nausea, vomiting, diarrhea, abdominal pain, loss of appetite.
• Laboratory Changes: Transient transaminase elevations, eosinophilia.

Symptoms:
Accidental or intentional severe overdose causes CNS toxicity: skin rash, edema, headache, dizziness, asthenia, nausea, vomiting, diarrhea, ataxia, seizures, stupor, or coma.

Treatment:
No specific antidote exists. Gastric lavage, activated charcoal, fluid replacement, and supportive care for blood pressure maintenance are indicated. Avoid GABA-agonist drugs.

Storage Requirements for Iversun-12:

• 🌡️ Temperature Control: Store in a dry, light-protected place at temperatures not exceeding 25–30 °C.
• 💧 Moisture Protection: Keep in original aluminum blister until administration.
• 👶 Safety Precautions: Keep strictly out of reach of children.
• ⏳ Shelf Life: Stated on blister strip and box. Do not use past expiration date. Prescription-only medicine.

To verify the authenticity of genuine Iversun-12 produced by Sunrise Remedies, check the following details:

• ✅ Corporate Logo: Authentic Sunrise Remedies company logo printed on outer carton and blister foil.
• ✅ Packaging Details: Clear factory printing displaying Batch No., Mfg. Date, and Exp. Date.
• ✅ Blister Quality: Sturdy aluminum blister containing 10 tablets with clear product lettering: Iversun-12 and Ivermectin Dispersible Tablets 12 mg.
• ✅ Print Quality: High-quality packaging artwork with precise color alignment and no typography errors.