Rothacin Rectal Suppositories

Indomethacin
100mg/Supp.
Julphar (Gulf Pharmaceutical Industries)
Pack size 10's (5's Strips x 2)
Dispensing mode POM
Source UAE
AgentJULPHAR
Retail Price 13.00 AED

Indications

Rothacin Rectal Suppositories is used for: Rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis (degenerative joint disease), gout, acute non-articular rheumatism (bursitis, synovitis, tendinitis).

Adult Dose

Oral Inflammatory/Rheumatoid Disorders Immediate release: 25-50 mg PO q8-12hr; not to exceed 200 mg/day Extended release: 75-150 mg/day PO in single daily dose or divided q12hr; not to exceed 150 mg/day Bursitis/Tendinitis Immediate-release: 75-150 mg/day PO divided q6-8hr Extended-release: 75-150 mg/day PO in single daily dose or divided q12hr Acute Gouty Arthritis 50 mg PO q8hr for 3-5 days; reduced once pain is under control Rectal Pain and inflammation associated with musculoskeletal and joint disorders Adult: As supp: 100 mg to be inserted at night and repeated in the morning if necessary.

Child Dose

Inflammatory/Rheumatoid Disorders <2 years: Safety and efficacy not established 2-14 years: 1-2 mg/kg/day PO divided q6-12hr; not to exceed 4 mg/kg/day or 150-200 mg/day >14 years: 25-50 mg IR PO q8-12hr; not to exceed 200 mg/day; 75-150 mg/day ER PO in single daily dose or divided q12hr; not to exceed 150 mg/day

Renal Dose

Administration

Take with food to avoid gastrointestinal (GI) effects

Contra Indications

Indomethacin is contraindicated in patients with ulcer, gastritis, active ulcerative colitis, and should be used with caution in patients with a history of these disorders. It is also contraindicated in previously hypersensitive patient.

Precautions

Patient w/ known CV disease or risk factors for CV disease, fluid retention, history of GI disease (e.g. bleeding or ulcers), history of mental depression or other psychiatric disorder, epilepsy, or parkinsonian syndrome; existing infection that is adequately controlled. May mask signs and symptoms of infection. Hepatic and renal impairment. Elderly, childn. Pregnancy and lactation. Lactation: Drug enters breast milk; use not recommended (American Academy of Pediatrics committee states that drug is compatible with nursing)

Pregnancy-Lactation

Pregnancy category: C Lactation: Drug enters breast milk; use not recommended (American Academy of Pediatrics committee states that drug is compatible with nursing)

Interactions

May increase plasma levels of methotrexate. Increased risk of GI bleeding w/ warfarin. May reduce hypotensive effects of hydralazine, furosemide, ?-blockers (e.g. atenolol, propranolol, oxprenolol), or thiazide diuretics. Increased risk of hyperkalaemia w/ K-sparing diuretics, ACE inhibitors, K supplements. May increase nephrotoxic effects of ciclosporin or triamterene. Increase plasma concentration w/ probenecid. May increase plasma levels of aminoglycoside (e.g. amikacin, gentamicin) in premature neonates. May enhance antipsychotic effect (e.g. severe drowsiness and confusion) of haloperidol. Al- or Mg-containing antacids may reduce GI disorders of indometacin. Potentially Fatal: Diflunisal decreases renal clearance and increases plasma concentrations of indometacin which leads to fatal GI haemorrhage.

Adverse Effects

Side effects of Indomethacin : >10% Transient renal insufficiency (40%), Jaundice (<15%), Elevated liver function test values (≤15%), Headache (12%) 1-10% Dizziness (3-9%), Dyspepsia (3-9%), Epigastric pain (3-9%), Indigestion (3-9%), Nausea (3-9%) Symptomatic upper GI ulcers, gross bleeding/perforation (4% of patients treated for 1 year; 1% of patients treated for 3-6 months). Abnormal pain/cramps/distress (<3%), Constipation (1-3%), Depression (1-3%), Diarrhea (1-3%), Fatigue (1-3%), Somnolence (1-3%), Tinnitus (1-3%), Vertigo (1-3%) <1% Acute interstitial nephritis with hematuria/proteinuria, Acute respiratory distress, Agranulocytosis, Angioedema, Aplastic anemia, Asthma, Bone marrow depression, Congestive heart failure (CHF), Hemolytic anemia, Leukopenia, Macular and morbilliform eruptions, Pulmonary edema, Thrombocytopenia, Thrombocytopenic purpura, Ulcerative stomatitis, Urticaria

Mechanism of Action

Indometacin, an indole acetic acid derivative has anti-inflammatory, analgesic and antipyretic actions. It reversibly inhibits cyclooxygenase-1 and -2 (COX-1 and -2) enzymes, thus resulting in reduced synthesis of prostaglandin precursors.

Note

Rothacin 100mg/Supp. Rectal Suppositories manufactured by Julphar (Gulf Pharmaceutical Industries). Its generic name is Indomethacin. Rothacin is availble in United Arab Emirates. Farmaco UAE drug index information on Rothacin Rectal Suppositories is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

Some other brands of Indomethacin :

Rectal Suppositories
Indocid 100mg
Algorithm S.A.L.
Capsules (Hard Gelatin)
Indocid Retard 75mg
Merck Sharp & Dohme B.V.
Capsules (Hard Gelatin)
Indocid Retard 75mg
Merck Sharp & Dohme B.V.
Capsules
Indogesic 25mg
Dar Al Dawa Development & Investment Co. Ltd.
Capsules (Hard Gelatin)
Indolag 50mg
Lagap SA