Molunheet — Molnupiravir 200 mg Capsules, 40 Caps

Molunheet is supplied in the form of capsules for oral administration with a carefully balanced composition of components:

• Form of Release and Packaging: 1 sealed plastic bottle made of high-density polyethylene (HDPE) with a protective tamper-evident cap. The bottle contains 40 capsules. Each bottle is packed in a branded cardboard box with protective markings and an original package insert.
• Active Ingredient:
  • Molnupiravir — 200 mg in each capsule.
• Excipients: Microcrystalline cellulose (filler), croscarmellose sodium (disintegrant), hydroxypropyl cellulose (binder), magnesium stearate (lubricant), titanium dioxide (pigment), purified water, gelatin (capsule shell), food colorants.

Pharmacodynamics: Molnupiravir is a prodrug that is metabolized in the body into an active ribonucleoside analog — N4-hydroxycytidine (NHC). Inside infected cells, NHC is phosphorylated under the action of cellular kinases to pharmacologically active triphosphate (NHC-TP). During viral RNA synthesis, the RNA-dependent RNA polymerase enzyme (both in SARS-CoV-2 and FCoV) mistakenly uses NHC-TP instead of cytidine or uridine. Upon repeated copying, these insertions cause massive mutational errors (G-to-A and C-to-U transitions). As a result, the viral genome loses the ability to encode functional proteins, leading to inactivation and death of viral particles.

Pharmacokinetics: After oral administration, molnupiravir is absorbed from the gastrointestinal tract at high speed. The maximum concentration of the active metabolite NHC in blood plasma (Cmax) is achieved on average after 1.5 hours. Food intake has no clinically significant effect on the degree of absorption. Binding of NHC to blood plasma proteins is negligible (less than 15%). The drug is distributed throughout all organs and tissues, including the lungs, liver, kidneys, as well as cerebrospinal fluid and eye tissues. The elimination half-life (T1/2) is approximately 3.3 hours. Excretion is carried out mainly by the kidneys and through the intestines.

Molunheet is used in the following clinical cases:

• 🔹 Human Medicine (COVID-19): Treatment of acute respiratory illness COVID-19 of mild and moderate severity in adult patients (18 years and older) with a laboratory-confirmed diagnosis (PCR or rapid test) who are at high risk of disease progression to a severe form (patients over 60 years old, individuals with diabetes mellitus, obesity, COPD, ischemic heart disease, oncology).
• 🔹 Veterinary Medicine (FIP in Cats):
  • Wet (effusive) form of infectious peritonitis (presence of ascitic effusion in the abdominal or pleural cavity).
  • Dry (non-effusive) form (granulomatous lesions of internal organs, lymph nodes, intestines).
  • Neurological form of FIP (ataxia, seizures, tremors, paresis, behavioral changes).
  • Ophthalmic (eye) form (uveitis, hyphema, corneal opacity, retinal precipitates).
  • Relapses of infectious peritonitis after previous therapy with other agents.

The dosing regimen and duration of intake are calculated based on the scope of application:

• 👨 For Humans (COVID-19 Therapy):
  • The standard dose is 800 mg (4 capsules of 200 mg) every 12 hours (2 times a day).
  • The course of treatment is strictly 5 days. The drug should be started within the first 5 days after the appearance of the first symptoms.
• 🐾 For Cats (FIP Therapy):
  • Applied 2 times a day with an interval of strictly 12 hours. Dosage is calculated based on animal body weight and clinical form:
  • Wet and Dry Forms (Uncomplicated): 10–15 mg/kg 2 times a day.
  • Neurological and Ocular Forms: 15–20 mg/kg 2 times a day (due to the need to maintain high concentration in the blood-brain barrier).
  • In Case of Relapses or Weak Response: The dose can be increased by a veterinarian up to 20–25 mg/kg 2 times a day.
  • The recommended veterinary course is from 84 days (12 weeks). Interrupting the course prematurely is not recommended even with complete normalization of blood tests and disappearance of symptoms.
• 🥤 Method of Administration: Capsules are taken orally. Humans swallow the capsule whole with water. For cats, it is acceptable to open the capsule, divide the powder into exact doses, and mix with a small amount of wet food, pate, or oily suspension immediately before feeding.

The use of Molunheet is strictly contraindicated under the following conditions:

• ❌ Individual hypersensitivity or allergic reactions to molnupiravir or any of the excipients of the capsule.
• ❌ Pregnancy at all stages and lactation period (both in human medicine and in breeding animals).
• ❌ Age under 18 years in humans (due to the risk of negative impact on bone and cartilage formation).
• ❌ Severe end-stage renal or hepatic impairment without the possibility of constant laboratory monitoring.

Features of Molunheet interaction with other pharmacological agents:

• ⚠️ Cytochrome P450 System: Molnupiravir and its metabolite NHC are not inhibitors or inducers of CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4 enzymes, so the risk of clinically significant interactions is minimal.
• ⚠️ Concomitant Therapy in Humans: Simultaneous administration with antihypertensive, hypoglycemic agents, analgesics, and antibiotics is permitted.
• ⚠️ Veterinary Protocol: Compatible with hepatoprotectors (ademetionine, silymarin), sorbents, antispasmodics, and vitamin complexes (B12). Simultaneous use with other strong hepatotoxic agents without regular blood biochemical monitoring is not recommended.

The use of Molunheet during pregnancy and lactation is strictly restricted:

• 🤰 Effect on the Fetus: Preclinical animal studies revealed reproductive and embryo-fetal toxicity (including teratogenicity and embryolethality). Prescription to pregnant women and female animals is prohibited.
• 🛡️ Contraception: Women of childbearing potential must use reliable methods of contraception while taking Molunheet and for 4 days after the last dose. Men taking the drug must use reliable contraceptive measures during therapy and for at least 3 months after its completion.
• 🤱 Lactation: Breastfeeding should be discontinued during administration and resumed no earlier than 4 days after the end of the course.

Molunheet is characterized by a good safety profile, however, the following side effects are possible:

• 🔴 Gastrointestinal Tract: Nausea, dyspepsia, diarrhea, vomiting, epigastric discomfort, flatulence.
• 🟡 Nervous System: Dizziness, headache, mild drowsiness.
• 🟠 Allergic Reactions: Skin rash, itching, urticaria, skin redness.
• 🐾 In Cats During Long Veterinary Course: Increased activity of liver enzymes (ALT, AST), temporary anorexia, stool softening, rare changes in coat quality. These symptoms are reversible and adjusted by a veterinarian.

Clinical manifestations and procedures in case of accidental exceedance of the recommended dose:

• Symptoms: In case of daily overdose, an increase in the severity of side effects from the digestive system (severe vomiting, multiple diarrhea) and pronounced dizziness are possible.
• Therapeutic Measures: A specific antidote has not been developed. Gastric lavage, administration of enterosorbents (activated charcoal, enterosgel), abundant drinking, or infusion therapy to prevent dehydration, as well as symptomatic support, are recommended.

Rules for storage and transportation of Molunheet:

• Temperature Range: Store in a dry place at a temperature from 15 °C to 25–30 °C.
• Protection from Environmental Factors: The bottle should be kept tightly closed in the original cardboard packaging, avoiding direct sunlight and high humidity.
• Safety: Keep out of reach of children and pets.
• Shelf Life: 24 months (2 years) from the date of manufacture. It is strictly forbidden to use the drug after the expiration date.

Criteria for verifying the authenticity of Molunheet produced by Heet Pharma:

• Packaging and Printing: The original box is made of high-quality dense cardboard. The design includes a white background, bright yellow geometric blocks, and a blue round logo. The name Molunheet is printed in a clear blue font without spelling errors.
• Branded Logo: The registered trademark Heet PHARMA® must be present on the box and bottle label.
• Factory Marking: On the side edge of the box and on the bottle label, data are entered by laser or thermal printing: manufacturing license number (Mfg. Lic. No.), batch number (Batch No.), manufacturing date (Mfg. Date), and expiration date (Exp. Date). Contacts of the manufacturer are also indicated: Heet Healthcare, Plot No. 13 & 14, Yadadri, R.R. District.