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Ranoxyl

Ranbaxy Nigeria Limited
24, Abimbola street, Abimbola House, Isolo, Lagos.
Tel: 234-1-7932744, 7913002
Fax: 234 1 7913003, 4526371

Brand Name

Ranoxyl

Manufacturer

Ranbaxy Lab. Ltd, Dewas, India

Therapeutic Class

Antibacterial, Penicillins

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Capsule (NRN: 04-0868): Amoxycillin Trihydrate BP equivalent to Amoxycillin 250 mg.

 

Pack: Ranoxyl Capsules 250 mg: Blister strip of 10’s; box of 10 x 10’s, 24 x 10’s, 50 x 10’s, 100 x 10’s, 10 x 20’s and 24 x 20’s, bottle of 1000’s.

 

 

Capsule (NRN: 04-2357): Amoxycillin Trihydrate BP equivalent to Amoxycillin 500 mg.

 

Pack: Ranoxyl Capsules 500 mg: Blister strip of 10’s; box of 10 x 10’s; 24 x 10’s, 50 x 10’s, 100 x 10’s, 10 x 20’s and 24 x 20’s, bottle of 500’s.

Pharmacology

Description 

Amoxycillin trihydrate is chemically designated as (6R)-6[-D-(4-hydroxyphenyl) glycyl amino] penicillanic acid trihydrate.

Mechanism of Action: Amoxycillin is an aminopenicillin and is a bactericidal drug like other penicillins. Its mechanism of action is similar to that of other penicillins. It inhibits bacterial cell wall synthesis and its activity depends on the ability to bind with the penicillin binding proteins (PBPs) located on the cell wall, thus interfering with peptidoglycan synthesis. Peptidoglycan provides the cell wall with mechanical stability. This inhibition results in the weakening of the bacterial cell wall and finally lysis and cell death.

Antibacterial activity: Amoxycillin has an antibacterial spectrum similar to that of other aminopenicillins. It is active against both Gram-positive and Gram-negative bacteria:

Gram-positive bacteria: Streptococci (including Streptococcus faecalis) Streptococcus pneumoniae and non-penicillinase producing Staphylococci, Listeria monocytogenes.

Gram-negative bacteria: H. influenzae, E. coli, P. mirabilis, N. gonorrhoeae, Salmonella spp., Shigella spp.

Pharmacokinetics:Amoxycillin is acid stable. It is rapidly and almost completely absorbed from the GIT (75 - 90%). Peak plasma concentrations of about 5 mcg per ml are achieved in 1-2 hours after a 250 mg dose and the drug can be detected in the plasma for upto 8 hours. Presence of food does not affect the total absorption of the drug. Amoxycillin is widely distributed in body tissues and fluids. It crosses the placenta and appears in breast milk. Distribution into the cerebrospinal fluid is low in subjects with non-inflamed meninges. The drug is about 20% protein bound and has a half-life of 1 - 1.5 hours. Amoxycillin is metabolised to a limited extent and about 60% is excreted in urine in six hours by glomerular filtration and tubular secretion. The drug achieves high concentrations in bile and some amount may be excreted in faeces.

Indications

Acute otitis media, pharyngitis, tonsillitis and sinusitis caused by Streptococci, Pneumococci, Non-penicillinase producing Staphylococci and Haemophilus influenzae.

- Lower respiratory tract infections including pneumonia, bronchitis and acute exacerbations of chronic bronchitis caused by susceptible organisms.

- Urinary tract infections caused by susceptible organisms.

- Skin and soft tissue infections including burn wound infections, caused by Streptococci, non-penicillinase-producing Staphylococci, E. coli and Proteus mirabilis.

- Helicobacter pylori associated gastritis or peptic ulcer - in combination with other drugs.

- Lyme disease

- Typhoid Fever

Contra-indications

Except under special cases, amoxycillin should not be used when the following conditions exist:

A history of allergic reaction to any of the penicillins/cephalosporins;

A history of antibiotic associated colitis;

Infectious mononucleosis

Precautions/Warnings

General:

The possibility superinfections with mycotic or bacterial pathogens should be kept in mind during amoxycillin therapy. If superinfections occur, the drug should be discontinue and/or appropriate therapy instituted. The efficacy of oestrogen containing contraceptives may be decreased by the concomitant administration of aminopenicillins. Care should be taken when high doses of amoxycillin are given to patients with renal impairment or congestive heart failure.

Amoxycillin therapy may produce false positive or falsely elevated test results with copper sulphate urine glucose tests. A false positive result may also occur with the Coomb’s test.

Warnings:

Before initiating therapy with amoxycillin or any other penicillins, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or cephamycins. There is clinical and laboratory evidence of partial cross-allergenicity of penicillins and cephalosporins.

Care should be taken when treating patients with syphilis as the Jarisch - Herxheimer reaction may occur. This reaction manifesting as fever, chills, headache and reactions at the site of the lesion, can be dangerous in cardiovascular syphilis or where there is a risk of increased local damage such as with optic atrophy.

Patients with a history of gastrointestinal disease, especially antibiotic associated colitis should be treated with amoxycillin with caution since penicillins may cause pseudomembranous colitis. As penicillins are known to cause skin rashes in infectious mononucleosis, amoxycillin should be used with caution in such cases.

Interactions

Probenecid decreases the renal tubular secretion of amoxycillin when co-administered resulting in higher and prolonged blood levels and possible increased risk of toxicity.

Amoxycillin may interact with oestrogen containing oral contraceptives leading to reduced contraceptive effect.

Laboratory value alterations:

Urine Glucose: High urinary concentration of amoxycillin may produce false-positive test results with copper sulphate tests.

Direct antiglobulin (Coombs’) tests: False-positive result may occur.

Adverse Effects

Adverse reactions reported with amoxycillin are:

Gastrointestinal reactions: Mild diarrhoea, nausea or vomiting, hepatotoxicity, hepatitis.

Allergic reactions: Fast or irregular breathing, puffiness or swelling around face, shortness of breath, sudden severe decrease in blood pressure, skin rash, hives itchings.

Mental disturbances: Anxiety, confusion, agitation, depression, seizures, hallucinations.

Haematological: Leucopenia or neutropenia.

Fungal infections: Oral candidiasis and vaginal candidiasis.

Use in Pregnancy and Lactation:

Reproduction studies in animals have revealed no evidence of teratogenicity. However, penicillins cross the placenta and safety in pregnant women has not been fully established. Therefore, amoxycillin should be used during pregnancy only if clearly needed.

Penicillins are also reported to appear in breast milk and though no significant reactions are reported in women, the use of these drugs may lead to sensitisation, diarrhoea and skin rash in infants; caution is required while giving amoxycillin to lactating women.

Paediatric Use:

Renal excretion of penicillins may be delayed in infants and neonates due to their incompletely developed renal function. Amoxycillin should be avoided in children less than 3 months of age.

Geriatric use:

As elderly patients are more likely to have age-related renal function impairment, necessary dosage adjustment may be required in such patients.

Dosage & Administration

Usual adult dose is 250-500 mg every eight hours; a dosage of 750 mg twice daily may also be used; in severe infections 750 mg can be administered thrice daily.

In Helicobacter pylori associated gastritis and/or gastric/duodenal ulcers, Ranoxyl should be given b.i.d or t.i.d along with acid-suppressive therapy.

In-Lyme disease, 250 - 500 mg three to four times a day for three to four weeks should be given.

Children:

 

 Body Weight   Dose  Frequency
 Up to 6 kg  25 - 50 mg  8 hourly
 6 - 8 kg  50 - 100 mg  8 hourly
 8 - 20 kg  6.7 - 13.3 mg/kg  8 hourly
 >20 kg  Adult dose  8 hourly

For Lyme disease: 6.7 - 13.3 mg/kg body weight every eight hours for ten to thirty days.

Ranoxyl Suspension is provided as a dry powder for reconstitution.

See bottle label for constitution. Shake well before use.

Overdosage

Since there is no specific antidote, treatment of amoxycillin overdose should be symptomatic and supportive. Haemodialysis may aid in the removal of amoxicillin from the blood.

Storage/Handling Recommendations

Store at a temperature not exceeding 25°C, protected from moisture.

After constitution store in a refrigerator at a temperature between 2 - 8°C, and use within 1 week.

Review Date

2016-06-25 10:16:43