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PP Obat

Amoxicillin

Indication & Dosage

Oral Gastroenteritis Adult: 250-500 mg every 8 hr or 500-875 mg every 12 hr. Child: 10 yr: 125-250 mg every 8 hr; <40 kg: 20-40 mg/kg daily in divided doses every 8 hr. Max dose: Infant <3 mth: 30 mg/kg daily in divided doses every 12 hr. Renal impairment: Patients on haemodialysis should receive 250-500 mg every 24 hr and an additional dose during and after each dialysis session.

CrCl (ml/min) Dosage Recommendation 10-30 250-500 every 12 hr. <10 250-500 every 24 hr.

Oral H.pylori infection Adult: 0.75 or 1 g bid or 500 mg tid in combination with either metronidazole or clarithromycin and a bismuth compound or an antisecretory drug. Renal impairment: Patients on haemodialysis should receive 250-500 mg every 24 hr and an additional dose during and after each dialysis session.

CrCl (ml/min) Dosage Recommendation 10-30 250-500 mg every 12 hr. <10 250-500 mg every 24 hr.
Parenteral Susceptible infections Adult: 500 mg every 8 hr via IM or slow IV inj. Severe infections: May increase to 1 g every 6 hr via slow IV inj over 3-4 minutes or infuse over 30-60 minutes. Child: 10 yr: 50-100 mg/kg daily in divided doses. Renal impairment: Patients on haemodialysis should receive 250-500 mg every 24 hr and an additional dose during and after each dialysis session.

CrCl (ml/min) Dosage Recommendation 10-30 250-500 mg every 12 hr. <10 250-500 mg every 24 hr.
Administration Contraindications Special Precautions Adverse Drug Reactions May be taken with or without food. May be taken w/ meals for better absorption & to reduce GI discomfort. Hypersensitivity. Renal and hepatic disease; pregnancy, lactation; infectious mononucleosis. Hyperactivity, agitation, insomnia, dizziness; maculopapular rash, exfoliative dermatitis, urticaria, hypersensitivity vasculitis; diarrhoea, nausea, vomiting; anaemia, thrombocytopenia, leucopenia, agranulocytosis. Potentially Fatal: Neuromuscular hypersensitivity; pseudomembranous colitis.

Drug Interactions

Increased levels with disulfiram and probenecid. Decreased effects with tetracyclines and chloramphenicol. Potentially Fatal: Increase effects of oral anticoagulants. Click to view more amoxicillin Drug Interactions

Pregnancy Category (US FDA) Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters). Storage Mechanism of Action Intravenous: Store at 20-25C. Parenteral: Store at 20-25C. Amoxicillin inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell wall by binding to one or more of the penicillin-binding proteins (PBPs), thus inhibiting cell wall biosynthesis resulting in bacterial lysis. Absorption: Rapidly and completely absorbed from the GI tract with peak plasma concentrations after 1-2 hr (oral). Not inactivated by gastric acid and presence of food does not impair absorption. Distribution: Widely distributed, CSF (small concentrations except when the meninges are inflamed), bile (high concentrations); crosses the placenta and enters the breast milk (small amounts). Protein-binding: 20%. Metabolism: Converted to a limited extent to penicilloic acid. Excretion: Via the urine within 6 hr by glomerular filtration and tubular secretion (as penicilloic acid and 60% unchanged drug); via the faeces. May be removed by haemodialysis; 1-1.5 hr (elimination half-life). Penicillins J01CA04 - amoxicillin ; Belongs to the class of penicillins with extended spectrum. Used in the systemic treatment of infections.

MIMS Class ATC Classification

Clarythromycin

Indication & Dosage

Oral Susceptible infections Adult: 250 mg bid increased to 500 mg bid for severe infections if necessary for 7-14 days. Child: 7.5 mg/kg bid for 5-10 days.

CrCl (ml/min) Dosage Recommendation <30 Half the dosage or double dosing interval.

Oral Eradication of H. pylori associated with peptic ulcer disease Adult: 500 mg bid; given in combination with another antibacterial and either a proton pump inhibitor or H2-receptor antagonist for 7-14 days. Child: 1 yr: 7.5 mg/kg bid; may be given with another antibacterial and a proton pump inhibitor for 7 days.

CrCl (ml/min) Dosage Recommendation

<30

Half the dosage or double dosing interval.

Intravenous Susceptible infections Adult: 500 mg bid for 2-5 days. Dose to be infused over 60 minutes in a 0.2% solution; revert to oral therapy whenever possible. Child: 1 mth-12 yr: 7.5 mg/kg every 12 hr. Dose to be given via infusion into proximal vein.

CrCl (ml/min) Dosage Recommendation <30 Half the dosage or double dosing interval.
Administration Overdosage Standard release tab & oral susp: May be taken with or without food. XL & MR tab: Should be taken with food. Swallow whole, do not chew/crush. GI symptoms e.g. abdominal pain, vomiting, nausea and diarrhoea. Prompt elimination of unabsorbed drug and supportive treatment should be instituted. Haemodialysis or peritoneal dialysis not expected to be helpful. Hypersensitivity. Patients receiving terfenadine, astemizole, pimozide, cisapride and ergot derivatives. Pregnancy; history of acute porphyria. Renal and hepatic impairment; macrolide cross-resistance; lactation, children. GI upset, glossitis, stomatitis, altered taste; headache, dizziness, hallucinations, insomnia, other CNS effects; rash; hepatic dysfunction, Potentially Fatal: Pseudomembranous colitis, anaphylaxis, Stevens-Johnson syndrome. May potentiate oral anticoagulant action. May elevate serum-digoxin concentration. Potentially Fatal: Increases plasma concentrations of terfenadine or astemizole. Increases the risk of ventricular arrhythmias in patients with preexisting cardiac diseases. Click to view more clarithromycin Drug Interactions Food may interfere with absorption though not clinically significant.

Contraindications Special Precautions Adverse Drug Reactions Drug Interactions

Food Interaction Pregnancy Category (US FDA)

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus. Storage Mechanism of Action Intravenous: Store at 15-25C. Clarithromycin inhibits protein synthesis by binding to 50s ribosomal subunits of susceptible organisms. It has activity against susceptible streptococci and staphylococci as well as other species including B. catarrhalis, L. spp, C. trachomatis and U. urealyticum. Absorption: Rapidly absorbed from the GI tract (oral). Distribution: Widely distributed (concentrations exceed those in serum); enters the breast milk. Metabolism: Hepatic (extensive); converted to 14-hydroxyclarithromycin and other metabolites. Excretion: Via the bile into the faeces; via the urine (20-30% as unchanged, 10-15% as 14-hydroxyclarithromycin and other metabolites).3-4 hr and 5-7 hr (elimination half-life) Macrolides J01FA09 - clarithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.

MIMS Class ATC Classification

Omeprazole

Indication & Dosage

Oral Peptic ulcer Adult: 20 mg daily as a single dose or 40 mg daily in severe cases. Treatment duration: Duodenal ulcers: 4 wk; gastric ulcers: 8 wk. Maintenance: 10-20 mg once daily. Hepatic impairment: Dose reduction may be necessary. Oral NSAID-associated ulceration Adult: 20 mg daily. Same dose may also be used for prophylaxis of ulceration in patients who require continued NSAID therapy. Hepatic impairment: Dose reduction may be necessary. Oral H.pylori infection Adult: Dose varies with regimen. As triple therapy: 20 mg bid or 40 mg once daily; requires combination therapy with antibiotics. Therapy is given for 1 wk. Omeprazole may be continued for another 4-8 wk on its own. Hepatic impairment: Dose reduction may be necesary. Oral Gastro-oesophageal reflux disease Adult: 20 mg once daily for 4 wk, may continue for another 4-8 wk if necessary. Maintenance: 10 mg daily. Child: Neonate, 1 mth-2 yr: 700 mcg/kg/day, may increase up to 3 mg/kg/day, or 20 mg daily. >2 yr: <20 kg: 10 mg once daily; 20 kg: 20 mg daily. Doses may be doubled if necessary. Hepatic impairment: Dose reduction may be necessary. Oral Acid-related dyspepsia Adult: 10 or 20 mg daily for 2-4 wk. Hepatic impairment: Dose reduction may be necessary. Oral Erosive oesophagitis Adult: 20 mg/day for 4-8 wk. Maintenance of healing: 20 mg/day for up to 12 mth of total therapy (including treatment period). Hepatic impairment: Dose reduction may be necessary. Intravenous Reflux oesophagitis Adult: By infusion over 20-30 minutes or slow inj over 5 minutes: 40 mg once daily until oral admin is possible. Hepatic impairment: Dose adjustment is required; a daily dose of 10-20 mg may be sufficient. Intravenous Gastric and duodenal ulcers Adult: By infusion over 20-30 minutes or slow inj over 5 minutes: 40 mg once daily until oral admin is possible. Hepatic impairment: Dose adjustment is required; a daily dose of 10-20 mg may be sufficient. Reconstitution: The solution for IV inj is obtained by adding to the vial 10 ml of the solvent

provided. (No other solvent should be used). The solution should be given over a period of at least 2.5 min at a max rate of 4 ml/minute; use within 4 hr of reconstitution. The solution for IV infusion is obtained by dissolving 1 vial in 100 ml saline for infusion or 100 ml 5% dextrose for infusion. The solution should be used within 12 hr when dissolved in saline and within 6 hr when dissolved in 5% dextrose. After reconstitution, start the infusion immediately. The constituted solution should not be mixed or co-administered in the same infusion set with any other drug. Infusion should be given over a period of 20-30 minutes. Administration MUPS tab: May be taken with or without food. Powd for oral susp: Should be taken on an empty stomach. Take on an empty stomach at least 1 hr before a meal. Cap: Should be taken with food. Take immediately before a meal. Confusion, drowsiness, blurred vision, tachycardia, nausea, flushing, diaphoresis, headache, and dry mouth. Treatment is supportive; not dialysable. Exclude malignancy, prolonged use, hepatic impairment. Pregnancy, lactation, children <1 yr. Elderly and Asians (increased bioavailability). Diarrhoea, nausea, fatigue, constipation, vomiting, flatulence, acid regurgitation, taste perversion, arthralgia, myalgia, urticaria, dry mouth, dizziness, headache, paraesthesia, abdominal pain, skin rashes, weakness, back pain, upper respiratory infection, cough. Potentially Fatal: Anaphylaxis. Decreases absorption of itraconazole, ketoconazole, dasatinib, oral iron salts. Decreases levels of nelfinavir. Increases levels of benzodiazepines (e.g. diazepam,midazolam, triazolam), HMG-CoA reductase inhibitor, CYP2C19 substrates (e.g. citalopram, diazepam, methsuximide, phenytoin, propranolol, and sertraline), and CYP2C9 substrates (e.g. bosentan, dapsone, fluoxetine, glimepiride, glipizide, losartan, montelukast, nateglinide, paclitaxel, phenytoin, warfarin, and zafirlukast). Decreased levels/effects with CYP2C19 inducers (e.g. aminoglutethimide, carbamazepine, phenytoin, and rifampin). Decreases excretion ofmethotrexate. Enhances the adverse/toxic effect of cilostazol. May alter the concentrations/effects of clozapine. Avoid concurrent use with clopidogrel. Click to view more omeprazole Drug Interactions Absorption may be delayed. St John's wort decreases omeprazole levels. Avoid ethanol (may cause gastric mucosal irritation). False negative results in the urea breath test.

Overdosage Special Precautions Adverse Drug Reactions

Drug Interactions

Food Interaction Lab Interference Pregnancy Category (US FDA)

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus. Storage Mechanism of Action Intravenous: Store at 15-30 C. Protect from light. Oral: Store at 15-30 C. Protect from light. Omeprazole suppresses gastric acid secretion by specific inhibition of the enzyme system hydrogen/potassium adenosine triphosphatase (H+/K+ ATPase) present on the secretory surface of the gastric parietal cell. Onset: Antisecretory: approx 1 hr; peak effect:0.5-3.5 hr. Duration: 72 hr. Absorption: Rapid but variable (oral); dose-dependent. Bioavailability: Oral: approx 3040%. Distribution: Protein-binding: 95%. Metabolism: Extensively hepatic; converted to hydroxyomeprazole and omeprazole sulfone. Excretion: Via urine (77%) and bile. Elimination half-life: 0.5-3 hr. Antacids, Antireflux Agents & Antiulcerants

MIMS Class

ATC Classification

A02BC01 - omeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).

Pyroxycam

Indication & Dosage

Oral Rheumatic disorders Adult: Initially, 20 mg daily as a single dose. Maintenance: 10-30 mg in single or divided doses. Oral Acute gout Adult: 40 mg daily for 5-7 days. Oral Juvenile idiopathic arthritis Child: 6 yr: <15 kg: 5 mg, 16-25 kg: 10 mg, 26-45 kg: 15 mg, 46 kg: 20 mg. Doses to be taken once daily. Topical/Cutaneous Local pain relief Adult: Apply a 0.5% gel 3-4 times daily over the affected area. Treatment should be reviewed after 4 wk. Should be taken with food. Symptoms are usually mild and include nausea and vomiting, headache, drowsiness, blurred vision and dizziness. Hypersensitivity, active peptic ulceration, porphyria, pregnancy (3rd trimester) and lactation. Elderly, childn <12 yr. Patients with infections, asthma, allergic disorders, haemorrhagic disorders or hypertension. Impaired renal, hepatic or cardiac function. Monitor for signs of liver, kidney, blood or eye disorders. GI disturbances, peptic ulcer, GI bleeding, headache, dizziness, blurred vision, tinnitus, skin rashes and pruritus. Haematological changes and photosensitivity. Potentially Fatal: Thrombocytopaenia and acute nephropathy. Toxic epidermal necrolysis and Stevens-Johnson syndrome. Increased risk of hyperkalaemia when used with ACE inhibitors and potassium-sparing diuretics. Convulsions may occur when used with quinolones. Effects of phenytoin and sulfonylureas may be enhanced. Antihypertensive effects of ACE inhibitors, -blockers and diuretics may be reduced. Increased risk of GI bleeding and ulceration when used with corticosteroids, SSRIs or antiplatelet agents. Increased risk of haematotoxicity when used with zidovudine. ACE inhibitors, ciclosporin, tacrolimus or diuretics may increase nephrotoxicity. Potentially Fatal: May potentiate anticoagulants. Increased levels of lithium, methotrexate and cardiac glycosides. Click to view more piroxicam Drug Interactions May interfere with thyroid function tests.

Administration Overdosage Contraindications Special Precautions

Adverse Drug Reactions

Drug Interactions

Lab Interference Pregnancy Category (US FDA)

Category C: Either studies in animals have revealed adverse effects on the foetus

(teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

in 3rd trimester or near delivery.


Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a lifethreatening situation or for a serious disease for which safer drugs cannot be used or are ineffective). Storage Mechanism of Action Oral: Store at <30C. Topical/Cutaneous: Store at <30C. Piroxicam is a NSAID, belonging to the oxicam group. It inhibits prostaglandin synthesis, reduces fever by acting on the heat-regulating center of the hypothalamus, inhibits plateletaggregating substance thromboxane A2 and reduces pain receptor sensitivity. It also exerts anti-inflammatory effect by lysosomal stabilisation, kinin and leukotriene production, alteration of chemotactic factors and neutrophil activation inhibition. Absorption: Well absorbed from the GIT (oral); peak plasma concentrations 3-5 hr after an oral dose. Distribution: Detected in breast milk. Protein-binding: 99% Metabolism: Hepatic via hydroxylation and conjugation; undergoes enterohepatic recycling. Excretion: Mainly in urine (as metabolites and unchanged drug), faeces; elimination halflife: 50 hr. Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) M01AC01 - piroxicam ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, oxicams. S01BC06 - piroxicam ; Belongs to the class of non-steroidal antiinflammatory agents. Used in the treatment of inflammation of the eye. M02AA07 - piroxicam ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.

MIMS Class ATC Classification