Dysmen

Approved Medical Indications:

A. Pain Management:

• Relief of mild to moderate acute pain, including:
• Headache
• Dental pain
• Musculoskeletal pain
• Postoperative pain

B. Gynecological Use:

• Primary dysmenorrhea (painful menstruation)
• Menorrhagia (heavy menstrual bleeding) – short-term use

C. Inflammatory Conditions:

• Symptomatic relief of pain and inflammation in osteoarthritis and rheumatoid arthritis (short-term use)

Off-label/Clinically Accepted Uses:

• Pain associated with intrauterine device (IUD) insertion
• Fever reduction (short-term use only)
• Management of migraine attacks when NSAIDs are tolerated

Route: Oral
Dosage Forms Available in Bangladesh: 250 mg and 500 mg capsules or tablets

Adults and Adolescents ≥14 Years:

• Acute pain and dysmenorrhea:
  500 mg orally as an initial dose, followed by 250 mg every 6 hours as needed
  Maximum duration: Up to 7 days
• Menorrhagia:
  500 mg three times daily, starting at the onset of menstruation and continuing for up to 4 days

Elderly:

• Use with caution; start at the lowest effective dose due to increased risk of gastrointestinal and renal adverse effects

Renal Impairment:

• Contraindicated in patients with moderate to severe renal dysfunction

Hepatic Impairment:

• Use with caution; monitor liver function in long-term therapy

Pediatric Use (<14 years):

• Safety and efficacy have not been established

Mefenamic acid is a nonsteroidal anti-inflammatory drug (NSAID) belonging to the fenamate group. It acts by reversibly inhibiting the cyclooxygenase (COX-1 and COX-2) enzymes, which are responsible for the conversion of arachidonic acid into prostaglandins. By reducing prostaglandin synthesis, mefenamic acid alleviates pain, inflammation, and fever. Its ability to reduce endometrial prostaglandins also helps in controlling uterine muscle contractions and heavy menstrual bleeding.

• Absorption: Rapid and complete after oral administration
• Time to Peak Plasma Concentration: 2–4 hours
• Bioavailability: Approximately 100%
• Protein Binding: >90%
• Metabolism: Extensively metabolized in the liver via the CYP2C9 enzyme system
• Half-life: Approximately 2 hours
• Excretion: Primarily excreted in the urine as glucuronide conjugates; minor amounts in feces

• Pregnancy:
• Category C (1st and 2nd trimesters): Use only if clearly necessary
• Category D (3rd trimester): Contraindicated due to risk of premature closure of the fetal ductus arteriosus
• Lactation:
• Mefenamic acid is excreted into breast milk in small amounts
• Use with caution during breastfeeding; monitor infants for diarrhea or irritability

• Primary Class: Nonsteroidal Anti-inflammatory Drug (NSAID)
• Subclass: Fenamate derivative (Anthranilic acid derivative)

• Known hypersensitivity to mefenamic acid, aspirin, or other NSAIDs
• History of NSAID-induced asthma, urticaria, or allergic reactions
• Active or history of gastrointestinal ulceration or bleeding
• Severe renal impairment
• Severe hepatic dysfunction
• Inflammatory bowel disease (e.g., ulcerative colitis)
• Third trimester of pregnancy

• Cardiovascular Risk: May increase the risk of myocardial infarction or stroke; use the lowest effective dose for the shortest duration
• Gastrointestinal Risk: Can cause GI bleeding, ulceration, and perforation, particularly in elderly or those with a history of ulcers
• Renal Effects: May cause renal toxicity; monitor kidney function especially in dehydrated or elderly patients
• Liver Effects: Monitor liver enzymes with long-term use
• Hypersensitivity Reactions: Risk of anaphylaxis, bronchospasm, and serious skin reactions
• CNS Effects: May cause drowsiness or dizziness; avoid activities requiring mental alertness until response is known

Common Side Effects:

• Gastrointestinal: Nausea, vomiting, abdominal pain, diarrhea, flatulence, indigestion
• CNS: Headache, dizziness, drowsiness
• Skin: Rash, itching

Serious/Rare Side Effects:

• Gastrointestinal bleeding or ulcer
• Hepatotoxicity (jaundice, elevated liver enzymes)
• Renal impairment or acute renal failure
• Anaphylactic reactions
• Blood disorders (e.g., hemolytic anemia, leukopenia)

Onset & Severity:

• GI and CNS side effects may occur early
• Risk of serious adverse effects increases with prolonged use or in high-risk patients

• Warfarin or other anticoagulants: Increased risk of bleeding
• Aspirin and other NSAIDs: Increased risk of GI toxicity; avoid combination
• Methotrexate: Increased serum methotrexate levels and potential toxicity
• Diuretics and ACE inhibitors: May reduce diuretic effectiveness and impair renal function
• Lithium: Increased lithium serum levels and risk of toxicity
• CYP2C9 inhibitors (e.g., fluconazole): May increase plasma concentrations of mefenamic acid

• FDA & EMA Alerts: Reinforced warnings about cardiovascular and gastrointestinal risks with prolonged NSAID use
• NICE Menorrhagia Guidelines: Mefenamic acid remains recommended for short-term use to reduce menstrual blood loss in women without contraindications
• Clinical Use Advisory: Emphasis on short-term treatment only; avoid use beyond 7 days due to increased toxicity risks

• Temperature: Store at 20°C to 25°C (68°F to 77°F)
• Humidity/Light: Protect from moisture and direct sunlight
• Handling Precautions: Store in a tightly closed container
• Reconstitution/Refrigeration: Not applicable (oral solid formulation only)