HPR-DS500 mg

HPR-DS is a fenamate-class non-steroidal anti-inflammatory drug (NSAID) used for the short-term relief of pain and for menstrual pain. Indications vary by strength of evidence:

Established / FDA-approved uses

• Mild-to-moderate pain in patients 14 years of age and older, when treatment is not expected to exceed 7 days.
• Primary dysmenorrhea (menstrual cramping pain not caused by an underlying pelvic condition).

Commonly used off-label (guideline/clinical-practice supported)

• Reduction of heavy menstrual bleeding (menorrhagia) as an adjunct measure, based on clinical studies rather than formal FDA approval.
• Symptomatic relief of other mild-to-moderate musculoskeletal or inflammatory pain, generally for short courses only.

HPR-DS is not intended for chronic, long-term use; it is indicated only for short courses of therapy.

Each capsule/tablet of Mefenamic acid contains Mefenamic acid BP/USP 250 mg or 500 mg as the active ingredient, along with standard pharmaceutical excipients (e.g., lactose, starch, magnesium stearate, and a capsule shell or tablet coating), depending on the manufacturer and formulation.

HPR-DS is a member of the fenamate (anthranilic acid derivative) class of non-steroidal anti-inflammatory drugs (NSAIDs). It possesses analgesic, anti-inflammatory, and antipyretic properties and is chemically distinct from, though pharmacologically related to, other NSAID subclasses such as the propionic acid derivatives (e.g., ibuprofen).

HPR-DS is typically supplied as oral capsules or tablets of 250 mg and 500 mg strength and is widely used for short-term pain relief, particularly for menstrual pain.

Non-Steroidal Anti-Inflammatory Drug (NSAID) – Fenamate (anthranilic acid) class

Mefenamic acid works primarily by non-selectively inhibiting the cyclooxygenase (COX-1 and COX-2) enzymes, which reduces the synthesis of prostaglandins — lipid mediators responsible for pain signaling, inflammation, and fever. By lowering endometrial prostaglandin concentrations, Mefenamic acid also reduces uterine contractility and menstrual blood loss, which underlies its usefulness in dysmenorrhea.

Mefenamic acid is rapidly absorbed after oral administration, reaching peak plasma concentrations within approximately 2–4 hours. It is highly protein-bound (over 90%), metabolized in the liver (primarily via CYP2C9), and excreted mainly via the kidneys, with a plasma elimination half-life of roughly 2–4 hours.

HPR-DS is for oral use only. Swallow the capsule/tablet whole with a full glass of water. Taking HPR-DS with food or milk can help reduce stomach upset. Do not lie down for at least 10 minutes after taking a dose. Do not crush or chew extended-release forms if prescribed.

Always inform the physician about all medications being taken before starting HPR-DS.

Common (may affect up to 1 in 10 people)

• Gastrointestinal: abdominal pain, dyspepsia, nausea, vomiting, diarrhea (reported somewhat more frequently with HPR-DS than with some other NSAIDs), constipation, flatulence
• Central nervous system: headache, dizziness, drowsiness
• Other: skin rash, tinnitus (ringing in the ears)

Less common but serious

• Peptic ulcer, gastrointestinal bleeding or perforation (can occur without warning)
• Elevated liver enzymes, hepatotoxicity
• Renal impairment, fluid retention, edema
• Cardiovascular thrombotic events (myocardial infarction, stroke)
• Hemolytic anemia (uncommon but recognized with HPR-DS) and other blood dyscrasias
• Bronchospasm or anaphylactoid reactions, especially in patients with aspirin/NSAID sensitivity

Seek medical attention promptly for signs of GI bleeding (black stools, vomiting blood), unexplained bruising/bleeding, yellowing of skin/eyes, or breathing difficulty.

Pregnancy: HPR-DS should be avoided starting at 20 weeks of pregnancy and onward, as NSAIDs at this stage can cause fetal renal dysfunction leading to oligohydramnios, and, if used at 30 weeks gestation or later, premature closure of the fetal ductus arteriosus. HPR-DS is contraindicated in the third trimester. Earlier in pregnancy, HPR-DS should be used only if clearly needed, at the lowest effective dose for the shortest possible duration, and only after consulting a physician, since the potential benefit must be weighed against potential risk to the fetus.

Lactation: HPR-DS passes into human breast milk in low amounts. Because of the potential for adverse effects in a nursing infant, a decision should be made whether to discontinue breastfeeding or discontinue HPR-DS, taking into account the benefit of breastfeeding and the mother's clinical need for the drug — consult a physician before use while breastfeeding.

Cardiovascular risk

HPR-DS, like other NSAIDs, may increase the risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use or in patients with existing cardiovascular risk factors or disease.

Gastrointestinal risk

HPR-DS can cause serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can occur at any time during use, with or without warning symptoms, and can be fatal. The risk is higher in the elderly and in those with a prior history of peptic ulcer disease or GI bleeding.

Duration of use

HPR-DS is not recommended for use beyond 7 days for pain relief without medical review, as safety data for longer courses are limited.

Renal and hepatic function

Long-term or high-dose use of HPR-DS can affect kidney function, including rare renal papillary necrosis; periodic monitoring is advised in patients with pre-existing renal or hepatic impairment, the elderly, or those on diuretics/ACE inhibitors.

Hematologic risk

HPR-DS can prolong bleeding time and, rarely, cause hemolytic anemia or other blood dyscrasias; use with caution in patients on anticoagulants or with pre-existing bleeding or hematologic disorders.

Other precautions

HPR-DS may mask signs of infection such as fever and inflammation. Use with caution in elderly patients, who are at greater risk of serious adverse effects, and in patients with asthma (risk of bronchospasm).

Symptoms of HPR-DS overdose may include drowsiness, lethargy, nausea, vomiting, epigastric pain, gastrointestinal bleeding, and, in severe cases, seizures (convulsions may be more prominent with HPR-DS overdose than with some other NSAIDs), or acute kidney injury.

Overdose of HPR-DS is a medical emergency. Seek immediate medical attention or contact a poison control center/emergency services. Treatment is supportive; activated charcoal may be given by medical personnel if the patient presents soon after ingestion. Do not attempt to treat an overdose at home without professional guidance.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Pediatric

HPR-DS is approved only for patients 14 years of age and older for pain, and for primary dysmenorrhea; safety and efficacy in children under 14 years have not been established.

Geriatric

Elderly patients are at greater risk of serious cardiovascular, gastrointestinal, and renal adverse effects with HPR-DS. Use the lowest effective dose for the shortest duration and monitor closely.

Renal/hepatic impairment

HPR-DS should be avoided in severe renal or hepatic impairment (see Contraindications); use with caution and monitoring in mild-to-moderate impairment.

Pregnancy and breastfeeding

See "Pregnancy and Lactation" section.

HPR-DS is intended for short-term use only: generally up to 7 days for acute pain, and typically 2–3 days (coinciding with the days of heaviest menstrual pain) for primary dysmenorrhea. Use beyond these periods should only occur under medical supervision.

Non-Steroidal Anti-Inflammatory Drug (NSAID); Fenamate (anthranilic acid derivative)

Mefenamic acid exerts its effects mainly through non-selective, reversible inhibition of cyclooxygenase enzymes (COX-1 and COX-2), thereby reducing the biosynthesis of prostaglandins from arachidonic acid. This reduction in prostaglandin production accounts for the analgesic, anti-inflammatory, and antipyretic effects of Mefenamic acid, and for its ability to reduce uterine prostaglandin levels and contractility in dysmenorrhea.

Category C (before 30 weeks gestation); Category D (at 30 weeks gestation and later)

HPR-DS is approved for use in patients 14 years of age and older for short-term treatment of mild-to-moderate pain and for primary dysmenorrhea. Safety and efficacy of HPR-DS in children younger than 14 years have not been established, and its use is therefore not recommended in this younger age group.