Inflam-D200 mg

Inflam-D is a nonsteroidal anti-inflammatory drug (NSAID), the active dextrorotatory (S(+)) enantiomer of racemic ibuprofen, indicated for the relief of pain and inflammation in a range of acute and chronic musculoskeletal and other conditions.

Established / Guideline-Supported Uses

• Symptomatic relief of pain and inflammation in osteoarthritis
• Symptomatic relief of pain, stiffness and inflammation in rheumatoid arthritis and other inflammatory arthropathies
• Mild to moderate musculoskeletal and soft-tissue pain (sprains, strains, back pain)
• Dental pain, including post-extraction pain
• Primary dysmenorrhoea (painful menstrual periods)
• Postoperative pain of mild to moderate intensity
• Fever and pain associated with common febrile/painful conditions in adults, as an analgesic-antipyretic

Adjunct Use

In chronic inflammatory joint disease, Inflam-D is often used as an adjunct to disease-modifying therapy for symptom control rather than as a disease-modifying agent itself.

Each tablet contains Dexibuprofen as the active ingredient, typically available in strengths of 200 mg and 400 mg. Formulations may be immediate-release or sustained/modified-release film-coated tablets, along with standard pharmaceutical excipients (fillers, binders, coating agents).

Inflam-D is a propionic acid derivative NSAID and is the single active enantiomer of the racemic mixture ibuprofen (which contains equal parts R(-) and S(+) ibuprofen). Only the S(+) enantiomer, Inflam-D, is pharmacologically active as a cyclooxygenase inhibitor; the R(-) form contributes little to anti-inflammatory activity. Because the entire dose is pharmacologically active, Inflam-D is generally administered at approximately half the milligram dose of racemic ibuprofen to achieve a comparable analgesic and anti-inflammatory effect.

Inflam-D is used for its analgesic, anti-inflammatory, and antipyretic properties in the management of pain and inflammatory musculoskeletal conditions.

Nonsteroidal Anti-Inflammatory Drug (NSAID) – Propionic acid derivative; Inflam-D is the active enantiomer of ibuprofen.

Mechanism

Dexibuprofen exerts its anti-inflammatory, analgesic and antipyretic effects by nonselective, reversible inhibition of cyclooxygenase (COX-1 and COX-2) enzymes, thereby reducing the synthesis of prostaglandins and thromboxanes from arachidonic acid. Reduced prostaglandin production at sites of tissue injury decreases sensitization of pain receptors and reduces the local inflammatory response; central prostaglandin inhibition contributes to its antipyretic effect.

Pharmacokinetics

• Absorption: Rapidly and almost completely absorbed after oral administration; peak plasma concentration typically reached within 1–2 hours.
• Protein binding: Highly protein bound (>99%), mainly to albumin.
• Metabolism: Extensively metabolized in the liver via oxidation (primarily CYP2C9) to inactive metabolites.
• Elimination: Elimination half-life of approximately 1.5–2.5 hours; excreted mainly via the kidneys as metabolites and, to a lesser extent, unchanged drug and conjugates.

Inflam-D should be taken orally, preferably with food, milk, or an antacid to reduce the risk of gastrointestinal irritation. Tablets should be swallowed whole with a full glass of water and not crushed or chewed unless the formulation is specifically designed for that purpose. Sustained-release formulations must not be split or crushed.

Inflam-D, like other NSAIDs, has clinically significant interactions with the following:

• Anticoagulants (e.g., warfarin) and antiplatelet agents: Increased risk of serious gastrointestinal and other bleeding due to additive effects on platelet function and mucosal integrity.
• Other NSAIDs and aspirin: Concomitant use increases the risk of gastrointestinal ulceration and bleeding without added therapeutic benefit; avoid combination.
• ACE inhibitors, angiotensin receptor blockers (ARBs), and diuretics: Inflam-D can reduce the antihypertensive effect of these agents and, when combined (the "triple whammy"), increases the risk of acute kidney injury, particularly in volume-depleted or elderly patients.
• Lithium: Inflam-D can reduce renal clearance of lithium, raising serum lithium levels and risk of toxicity; monitor lithium levels if co-administered.
• Methotrexate: Inflam-D can reduce renal clearance of methotrexate, increasing risk of methotrexate toxicity, especially at higher methotrexate doses.
• Selective serotonin reuptake inhibitors (SSRIs): Combined use increases the risk of gastrointestinal bleeding due to additive effects on platelet function and gastric mucosa.
• Corticosteroids: Increased risk of gastrointestinal ulceration and bleeding when used together with Inflam-D.

Common

• Gastrointestinal upset, dyspepsia, nausea, heartburn
• Headache
• Dizziness

Less Common but Clinically Important

• Gastrointestinal ulceration and bleeding
• Renal impairment or fluid retention
• Hypertension or worsening of existing hypertension
• Peripheral edema
• Skin rash or hypersensitivity reactions

Serious cardiovascular thrombotic events (heart attack, stroke) and serious gastrointestinal events (bleeding, ulceration, perforation) can occur at any time during use of Inflam-D, with or without warning symptoms, and risk increases with duration of use (see Precautions and Warnings).

Inflam-D should be avoided during the third trimester of pregnancy, as NSAIDs at this stage are associated with premature closure of the fetal ductus arteriosus and can cause oligohydramnios and fetal renal dysfunction. Use during the first and second trimesters, and around conception, should be avoided unless clearly necessary; if used, the lowest effective dose for the shortest possible duration should be employed, only if the potential benefit justifies the potential risk to the fetus, and under medical supervision.

Small amounts of Inflam-D may pass into breast milk. Use during breastfeeding should only occur if considered essential by a physician, weighing the benefit to the mother against potential risk to the infant; a physician should be consulted before use in nursing mothers.

Cardiovascular Risk

NSAIDs, including Inflam-D, may increase the risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may increase with duration of use and may be higher in patients with existing cardiovascular disease or risk factors. Inflam-D is contraindicated for the treatment of pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk

NSAIDs, including Inflam-D, can cause serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use, without warning symptoms, and are more common in elderly patients, those with a prior history of peptic ulcer disease or GI bleeding, and those taking anticoagulants, corticosteroids, or other NSAIDs concurrently (see Interactions).

Renal Effects

Long-term use of Inflam-D can impair renal function, particularly in patients with pre-existing renal impairment, heart failure, liver dysfunction, volume depletion, or in the elderly. Adequate hydration should be maintained and renal function monitored in at-risk patients.

Hepatic Effects

Elevations of liver enzymes may occur; discontinue if signs of liver dysfunction develop.

Hypersensitivity and Skin Reactions

Inflam-D can cause serious skin reactions and anaphylactoid reactions, even without prior exposure; discontinue at first appearance of skin rash or other signs of hypersensitivity.

General

Use the lowest effective dose for the shortest duration necessary. Use with caution in patients with asthma, fluid retention, hypertension, or a history of gastrointestinal disease.

Symptoms of Inflam-D overdose may include nausea, vomiting, abdominal pain, drowsiness, dizziness, headache, tinnitus, and in severe cases, gastrointestinal bleeding, hypotension, respiratory depression, metabolic acidosis, renal impairment, and, rarely, seizures or coma.

If overdose is suspected, seek immediate medical attention or contact a poison control center / emergency services right away. Treatment is supportive and symptomatic; management should only be carried out by qualified medical personnel in a healthcare facility. Do not attempt home treatment.

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

Elderly

Elderly patients are at greater risk for serious gastrointestinal, cardiovascular and renal adverse effects with Inflam-D; use the lowest effective dose for the shortest duration and monitor closely.

Renal Impairment

Use with caution in mild-to-moderate renal impairment; contraindicated in severe renal impairment (see Contraindications).

Hepatic Impairment

Use with caution in mild-to-moderate hepatic impairment; contraindicated in severe hepatic impairment (see Contraindications).

Pregnancy and Lactation

See Pregnancy and Lactation section.

Pediatric Patients

Safety and efficacy have not been well established in children; use is generally not recommended in this population (see Pediatric Uses).

Inflam-D should be used for the shortest duration consistent with the treatment goal. For acute pain (e.g., dental, musculoskeletal, dysmenorrhoea), a few days of use is usually sufficient. For chronic inflammatory conditions such as osteoarthritis or rheumatoid arthritis, longer-term use may be required under regular medical review, with periodic reassessment of the need for continued therapy given cardiovascular and gastrointestinal risks that increase with duration of use.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs); Propionic acid derivatives

Dexibuprofen nonselectively and reversibly inhibits cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes, blocking conversion of arachidonic acid to prostaglandin precursors. This reduces the synthesis of prostaglandins that mediate pain, inflammation, and fever, producing analgesic, anti-inflammatory, and antipyretic effects.

Safety and efficacy of Inflam-D have not been well established in pediatric patients, and it is generally not recommended for use in children. If pain or fever management is needed in a child, alternative agents with established pediatric dosing and safety data should be considered under medical guidance.