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Romycin 500
The Ibn Sina Pharmaceutical Ind. Ltd.
Generic: Azithromycin
Safety Advices
বাংলা
English
UNSAFE
It is unsafe to consume alcohol with Romycin 500.
SAFE IF PRESCRIBED
Romycin 500 is generally considered safe to use during pregnancy. Animal studies have shown low or no adverse effects to the developing baby; however, there are limited human studies.
SAFE IF PRESCRIBED
Romycin 500 is safe to use during breastfeeding. Human studies suggest that the drug does not pass into the breastmilk in a significant amount and is not harmful to the baby.
There may be a possibility of diarrhea or rash in the baby.
SAFE
Romycin 500 does not usually affect your ability to drive.
CAUTION
Romycin 500 should be used with caution in patients with severe kidney disease. Dose adjustment of Romycin 500 may be needed. Please consult your doctor.
CAUTION
Romycin 500 should be used with caution in patients with liver disease. Dose adjustment of Romycin 500 may be needed. Please consult your doctor.
Medicine Overview of Romycin 500mg Tablet
Introduction
Romycin 500 is an antibiotic used to treat various types of bacterial infections of the respiratory tract, ear, nose, throat, lungs, skin, and eye in adults and children. It is also effective in typhoid fever and some sexually transmitted diseases like gonorrhea. Romycin 500 is a broad-spectrum type of antibiotic effective in killing many types of gram-positive bacteria, some types of gram-negative bacteria and other microorganisms. This medicine is taken orally, preferably either one hour before or 2 hours after a meal. It should be used regularly at evenly spaced time intervals as prescribed by your doctor. Do not skip...
... Show moreUses of Romycin 500
- Bacterial infections
Side effects of Romycin 500
Common
- Vomiting
- Nausea
- Abdominal pain
- Diarrhea
How to use Romycin 500
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Romycin 500 may be taken with or without food, but it is better to take it at a fixed time.
How Romycin 500 works
Romycin 500 is an antibiotic. It works by preventing synthesis of essential proteins required by bacteria to carry out vital functions. Thus, it stops the bacteria from growing, and prevents the infection from spreading.
What if you forget to take Romycin 500?
If you miss a dose of Romycin 500, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.
Quick Tips
- Do not skip any doses and finish the full course of treatment even if you feel better. Stopping it early may make the infection to come back and harder to treat.
- Take it 1 hour before or two hours after food.
- Do not take antacids 2 hours before or after taking Romycin 500.
- Diarrhea may occur as a side effect but should stop when your course is complete. Inform your doctor if it doesn't stop or if you find blood in your stools.
- Stop taking Romycin 500 and inform your doctor immediately if you develop an itchy rash, swelling of the face, throat or tongue or breathing difficulties while taking it.
Brief Description
Indication
Bacterial infections, bacterial endocarditis, typhoid fever, community-acquired pneumonia, uncomplicated gonorrhea, streptococcal pharyngitis/tonsillitis, COPD, acute bacterial sinusitis, acute otitis media, uncomplicated UTI, Uncomplicated gonorrhea, PID, non-gonococcal urethritis, chancroid, acute salmonellosis, cervicitis, babesiosis, chlamydial infections, pelvic inflammatory disease, PID, traveler's diarrhea,
Administration
Oral Administration Tablet: Take tablets without regard to food; however, food may enhance tolerability Oral suspension Conventional oral suspension (100 mg/5 mL, 200 mg/5 mL) may be stored for 10 days after reconstitution and taken without regard to food Conventional 1 g package must be taken immediately after reconstitution Extended-release oral suspension must be taken on empty stomach within 12 hours of reconstitution; given only in single dose; not interchangeable with immediate release formulation IV Preparation Dilute 500-mg vial in 4.8 mL of SWI (100 mg/mL) Dilute further in NS to 1 mg/mL (500 mL) or 2 mg/mL (250 mL)...
... Show moreAdult Dose
Adult: PO Resp tract infections; Skin and soft tissue infections 500 mg once daily for 3 days. Chancroid; Non-gonococcal cervicitis/urethritis due to Chlamydia trachomatis; Uncomplicated genital infections due to Chlamydia trachomatis 1 g as a single dose. Prophylaxis of disseminated MAC infections 1.2 g once wkly. Treatment or secondary propjhylaxis: 500 mg once daily w/ other antimycobacterials. Uncomplicated gonorrhoea 2 g as a single dose. Granuloma inguinale Initial: 1 g, then 500 mg/day until all lesions have healed completely. Active immunisation against typhoid fever caused by Salmonella typhi 1 g once daily for 5 days. IV Community-acquired pneumonia 500 mg...
... Show moreChild Dose
Child: PO: q24h
Otitis: 10 mg/kg/day for 1 day, then 5 mg/kg for 4 days; or 10 mg/kg/day for 3 days; or 30 mg/kg once.
Pharyngitis: 12 mg/kg/day for 5 days.
Sinusitis: 10 mg/kg/day for 3 days.
CABP: 10 mg/kg for 1 day, then 5 mg/kg/day for 4 days or 60 mg/kg once of ER susp
MAC/PCP prophylaxis: 5 mg/kg/day
IV: 10 mg/kg q24h
>6 mth 10 mg/kg;
15-25 kg: 200 mg;
26-35 kg: 300 mg;
36-45 kg: 400 mg.
All doses to be taken once daily for 3 days.
Renal Dose
Renal impairment: No dosage adjustment needed.
Contraindication
Known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic. Coadministration w/ pimozide. History of cholestatic jaundice/hepatic dysfunction associated w/ prior use of azithromycin.
Mode of Action
Azithromycin is a semisynthetic azalide antibiotic. It blocks transpeptidation by binding to 50s ribosomal subunit of susceptible organisms and disrupting RNA-dependent protein synthesis at the chain elongation step.
Precaution
May increase the risk of Torsades de pointes and fatal heart arrhythmias in patients w/ prolonged QT interval, low K or Mg blood levels, slow heart rate and medication treating abnormal heart rhythms. Impaired hepatic and renal function. Pregnancy and lactation. Monitoring Parameters Liver function tests, CBC w/ differential.
Lactation: Unknown whether drug is excreted into breast milk; use with caution
Side Effect
>10%
High single dose therapy
Diarrhea (52.8%),Nausea (32.6%),Abdominal pain (27%),Loose stool (19.1%)
1-10%
Cramping (2-10%),Vaginitis (2-10%),Dyspepsia (9% with single high dose therapy),Flatulence (9% with single high dose therapy),Vomiting (6.7% with single high dose therapy),Malaise (1.1%)
<1%
Agitation,Allergic reaction,Anemia,Anorexia,Candidiasis,Chest pain,Conjunctivitis,Constipation,Dermatitis (fungal),Dizziness,Eczema,Edema,Enteritis,Facial edema,Fatigue,Gastritis,Headache,Hyperkinesia,Hypotension,Increased cough,Insomnia,Leukopenia,Malaise,Melena,Mucositis,Nervousness,Oral candidiasis,Pain,Palpitations,Pharyngitis,Pleural effusion,Pruritus,Pseudomembranous colitis,Rash,Rhinitis,Seizures,Somnolence,Urticaria,Vertigo
Potentially Fatal: Angioedema and cholestatic jaundice.
Pregnancy Category Note
Pregnancy Available data from published literature and postmarketing experience over several decades with azithromycin use in pregnant women have not identified drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data); data do not suggest embryofetal risk (Developmental and Reproductive Toxicology Database [DART]; https://toxnet.nlm.nih.gov/newtoxnet/dart.htm) Animal data Developmental toxicity studies with azithromycin in rats, mice, and rabbits showed no drug-induced fetal malformations at doses up to 4, 2, and 2 times, respectively, an adult human daily dose of 500 mg based on body surface area; decreased viability and delayed development were observed in offspring of pregnant...
... Show moreInteraction
Increases serum concentrations of digoxin, ciclosporin, terfenadine, hexobarbital and phenytoin. Decreased rate of absorption w/ antacids containing aluminium and magnesium. Increased risk of ergot toxicity.
Potentially Fatal: Increased risk of cardiotoxicity w/ pimozide.
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