Metrotab Metronidazole Tablets and Syrup

Metrotab TABLETS AND SYRUP

 

COMPOSITION

The active ingredient in Metrotab and Metropaed is Metronidazole 2 (2 – methyl -5-nitroimidazol – 1 -yl)ethanol.

 

PRESENTATIONS

Tablets: Metrotab 200 comes as a white, round, biconvex uncoated and scored tablet embossed MTZ 200 on one side and SKG on the other and contains 200mg Metronidazole B.P. Metrotab 400 comes as a yellow coloured round, biconvex, uncoated and scored tablet embossed MTZ 400 on one side and SKG on the other and contains 400mg Metronidazole B.P.

Suspension: Metropaed comes as a yellow coloured, flavoured suspension. Each 5ml of the suspension contains 200mg Metronidazole B.P.

 

PROPERTIES

Metrotab and metropaed have activity against several protozoa including Balantidium coli, Blastocystis hominis, Entamoeba histolytica and Giardia intestinalis. It is bactericidal to most obilgate and facultative anaerobes like Bacteroides, CIostridium spp., Gardnerella vaginalis and Heliabacter pylori.

 

INDICATIONS

Metrotab and metropaed are indicated for the treatment of amoebiasis at all sites of infection with Entamoeba histolytica, Glardiasis, Bacterial vaginosis, Trichomoniasis, Pelvic inflammatory disease. Prevention and treatment of post operative anaerobic infections and Acute necrotising ulcerative gingivitis. Metrotab and Metropaed are also indicated for the eradication of Helicobater pylori in Peptic ulcer disease, legs ulcers and Pressure sores infected with anaerobic bacteria, Balantidiasis and Blastocystis hominis infections, acute dental infections and anaerobic bacterial infections.

 

MODE OF ACTION

Both metrotab and Metropaed exert their activity through interference with DNA by a metabolite in which the nitro group of metronidazole has been reduced.

 

DOSAGE AND ADMINISTRATION

Metrotab and Metropaed should be taken at least 1 hour before food.

 

RECOMMENDED DOSAGE

DURATION OF DOSES (DAYS) ADULTS AND
CHILDREN
10 YEARS OLD
7-10 YEARS 3-7 YEARS 1-3 YEARS
TABLETS SUSPENSION
AMOEBIASIS
1. Acute invasive intestinal disease in susceptible patients
5 800mg Three times daily 10ml three times daily 5ml four times daily 5ml three times daily
2. Intestinal disease in less susceptible patients with Chronic amoebic hepatitis 5-10 400mg Three
times daily
5ml three times daily 2.5ml four times daily 2.5ml three times daily
3. Other forms of
Amoebiasis including Amoebic liver abscess
5 400mg Three times daily 5ml three times daily 2.5ml four times daily 2.5ml three times daily
4. Sysmptomless cyst Passers 5-10 400mg -800mg three times daily 5ml-10ml three times daily 5m1-10ml
three times daily
2.5ml-5ml three times daily
5. UROGENITAL
TRICHOMONIASIS
In cases of likely reinfection, a second course of treatment should be done concurrently
2 800mg in the morning and 1.2g In the evening 5ml-10ml three times daily 5ml-10ml
three times daily
2.5ml-5ml
three times daily
6. GIARDIASIS
If necessary, repeat Treatment after 2 weeks
3 2g once daily 25ml once
daily
15ml once daily 10ml once daily
7. ACUTE ULCERATIVE GINGIVITIS 3 200mg three times daily 2.5ml three times daily 2.5ml twice daily 1.2ml
three times daily

 

SIDE EFFECTS

At the recommended dosage, side effect are uncommon. The commonly reported effects include headache, weakness drowsiness, gastrointestinal disturbance like nausea, vomiting and diarrhoea, an unpleasant metallic taste, furry tongue, glossitis, stomatitis, skin rashes, pruritus urticana, darkening of the urine, insomnia and changes in mood or mental state such as depression and or confusion. Transient epileptiform seizures and peripheral neuropathy have also been reported but these are associated with prolonged treatment or high doses of metronidazole.

 

PRECAUTIONS AND WARNINGS

In patients with severe hepatic impairment, doses should be reduced. Clinical and laboratory monitoring is advised in patients receiving Metronidazole for more than 10 days, since prolonged treatment have sometimes been associated with leucopoenia and transient epileptiform seizures.

The use of Metronidazole should be avoided in pregnancy. Alcoholic beverages should not be taken while on Metronidazole therapy.

 

CONTRAINDICATIONS

Metrotab and metropaed are contra-indicated in cases of known hypersensitivity to metronidazole.

 

STORAGE

Adult Tablets: store below 35°C and protect from light.

Paediatric Suspension: store below 25°C and protect from light.

 

Shake the bottle well before use.

 

KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN

 

Manufactured in Nigeria by

SKG – Pharma Limited

7/9 Sapara Street,

Ikeja, Lagos.

M&B Cipro Ciprofloxacin Caplets

M&B CIPRO™
(Ciprofloxacin Caplets)

 

PROPRIETARY NAME (and dosage form)

M & B Cipro 500mg caplets by 10’s

 

COMPOSITION

Each caplet contains 500mg Ciprofloxacin

 

PHARMACOLOGICAL CLASSIFICATION

Antibacterial

 

PHARMACOLOGICAL ACTION

Bactericidal by inhibition of DNA supercoiling in the bacteria. It accomplishes this by inhibiting the enzyme DNA gyrase. Ciprofloxacin is one of the most active fluroquinolones against Gram-negative aerobic bacteria including Enterobacteriacae e.g Salmonella, Klebsiella and Shigella species. Haemophilus, Neisseria, Campylobacter and Pseudomonas species. It is also active in vitro against many Gram-positive aerobic pathogens including penicillinase producing and methicillin-resistant Staphylococci.

 

INDICATIONS AND USAGE

M & B Cipro caplets 500mg are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below.

1. Lower respiratory tract infections caused by Haemophilus influenza, H. paraininfluenzae, E. coli, Klebsiella pnuemoniae, Enterobacter cloacae, Proteus mirabilis, and Pseudomonas aeruginosa, Chlamydia and some mycobateria.

2. Urinary Tract Infection

3. Skin and Skin Structure Infections

4. Acute Uncomplicated Cystitis in females caused by Escherichia coli or Staphylococcus saprophyticus. And Chronic Bacterial Prostatitis caused by Escherichia coli or Proteus mirabilis.

5 Uncomplicated cervical and urethral gonorrhea due to Neisseria gonorrhea.

 

DOSAGE AND ADMINISTRATION

Dosage depends on the severity and nature of infection. Unless prescribed otherwise, the following doses are recommended:

Urinary Tract Infections: Mild to Moderate: 250mg twice daily. Severe: 500mg twice daily.
Lower Respiratory Tract Infections: Mild to Moderate: 500mg twice daily. Severe: 750mg twice daily.

Urethral and Cervical Gonococcal Infection: Uncomplicated: 250mg single dose. The recommended adult dosage for chronic bacterial prostatitis is 500mg twice daily. In acute uncomplicated cystitis in females, the usual dosage is 250mg twice daily.

Skin and skin structure infections may be treated with 500mg twice daily.

 

CONTRAINDICATIONS

Hypersensitivity to the drug and other quinolones. Growing adolescents, unless benefits outweigh risks. Children below 12 years, Ciprofloxacin should not be administered to pregnant or lactating mothers.

Contra indicated in co-administration with drugs primarily metabolized by the enzyme CYPIA2 (G6PD deficiency).

 

SIDE EFFECTS

Side effects may include dizziness, headache, tremor, blurred vision, convulsion, confusion, and GIT disturbances. Judgment and dexterity may be impaired. Transient increases in serum creatinine. Haemotological, hepatic and renal disturbances.

 

DRUG INTERACTIONS

Theophylline metabolism is inhibited (Monitor theophylline levels). Concomitant administration of Ciprofloxacin with theophylline decreases the clearance of theophylline resulting in elevated serum theophylline levels and increased risk of a patient development CNS or other adverse reactions. Serum concentration reduced by antacids. Potentiates oral anticoagulants.

 

PRECAUTIONS AND WARNINGS

Ciprofloxacin should be used with caution in patients with suspected or known CNS disorders such as arteriosclerosis or epilepsy or other factors which predispose to seizures myasthenia gravis and renal impairment.

Liberal intake of water is advised during the use of ciprofloxacin.

Caution should be taken when used with products containing calcium, Iron and Zinc (See antacid interaction above). They can be taken two hours after or six hours before the drug.

Should not be used for pneumococcal pneumonia and most anerobic organism are not susceptible.

 

STORAGE

Store in a cool, dark and dry place.

Keep this medication out of the reach of children.

 

PRESENTATION

Ciprofloxacin 500mg caplets by 10’s.

 

Manufactured by

May & Baker Nigeria Plc.

1, May & Baker Avenue, Off Idiroko Road,

(Opposite Covenant University)

Ota, Ogun State, Nigeria.

http://www.may-baker.com

Batina Tinidazole Tablets

BATINA®
Tinidazole Tablets B.P. 500mg

 

DRUG DESCRIPTION

Each tablet contain 500mg of tinidazole.

Tinidazole is a synthetic antiprotozoal and antibacterial agent. It is 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitroimidazole, a second-generation 2-methyl-5-nitroimidazole.

 

INDICATIONS

1. Trichomoniasis
Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomoras vaginalis. The organism should be identified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, partners of infected patients should be treated simultaneously in order to prevent re-infection.

2. Giardiasis
Tinidazole is indicated for the treatment of giardiasis caused by Giardia duodenalis (also termed G. lamblia) in both adults and pediatric patients older than three years of age.

3. Amebiasis
Tinidazole is indicated for the treatment of intestinal amebiasis and amebic liver abscess caused by Entamoeba histolytica in both adults and pediatric patients older than three years of age. It is not indicated in the treatment of asymptomatic cyst passage.

4. Bacterial Vaginosis
Tinidazole is indicated for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, or anaerobic vaginosis) in non-pregnant women.

Other pathogens commonly associated with vulvovaginitis such as Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans and Herpes simplex virus should be ruled out.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of tinidazole and other antibacterial drugs, tinidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

 

DOSAGE AND ADMINISTRATION

Dosing Instructions

It is advisable to take tinidazole with food to minimize the incidence of epigastric discomfort and other gastrointestinal side-effects. Food does not affect the oral bioavailability of tinidazole.

Alcoholic beverages should be avoided when taking tinidazole and for 3 days afterwards.

Trichomoniasis

The recommended dose in both females and males is a single 2 g oral dose taken with food. Since trichomoniasis is a sexually transmitted disease, sexual partners should be treated with the same dose and at the same time.

Giardiasis

The recommended dose in adults is a single 2 g dose taken with food. In pediatric patients older than three years of age, the recommended dose is a single dose of 50 mg/kg (up to 2 g) with food.

Amebiasis

Intestinal: The recommended dose in adults is a 2 g dose per day for 3 days taken with food. In pediatric patients older than three years of age, the recommended dose is 50 mg/kg/day (up to 2 g per day) for 3 days with food.

Amebic Liver Abscess: The recommended dose in adults is a 2 g dose per day for 3-5 days taken with food. In pediatric patients older than three years of age, the recommended dose is 50 mg/kg/day (up to 2 g per day) for 3-5 days with food. There are limited pediatric data on durations of therapy exceeding 3 days, although a small number of children were treated for 5 days without additional reported adverse reactions. Children should be closely monitored when treatment durations exceed 3 days.

Bacterial Vaginosis

The recommended dose in non-pregnant females is a 2 g oral dose once daily for 2 days taken with food or a 1 g oral dose once daily for 5 days taken with food. The use of tinidazole in pregnant patients has not been studied for bacterial vaginosis.

As directed by physician.

 

CONTRAINDICATIONS

The use of tinidazole is contraindicated:

1. In patients with a previous history of hypersensitivity to tinidazole or other nitroimidazole derivatives. Reported reactions have ranged in severity from urticaria to Stevens-Johnson syndrome.

2. During first trimester of pregnancy.

3. In nursing mothers: Interruption of breast-feeding is recommended during tinidazole therapy and for 3 days following the last dose.

 

SIDE EFFECTS

Bitter/metallic taste in the mouth, nausea, vomiting, upset stomach, stomach cramps/pain, loss of appetite, constipation, diarrhea, dizziness, or drowsiness may occur.

If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
This drug may cause your tongue or urine to darken. This is harmless.

 

PHARMACOLOGY

Mechanism of action

The mode of action is thought to involve reduction by bacterial ‘nitroreductases’ to an unstable intermediate which interacts with DNA, effectively preventing further replication.

Antibacterial Spectrum

Tinidazole has well established bactericidal activity against obligate anaerobic in vitro, including the Gram-negative organisms. Bacteroides fragilis and other bacteroides spp., fusobacterium spp., and veillonella spp., and the grain positive organisms clostridium difficile, C1 perfringens, and other clostridium spp., Eubacterium spp., peptococcus spp., and peptostraptococcus spp., propionibacterium and Actinomyces spp. It is also active on H. pylori.

Pharmacokinetics

Tinidazole is almost completely absorbed following administration by mouth and typically, a peak plasma concentration of about 40µg per ml is achieved 2 hours after a single 2 g dose, falling to about 10µg/ml at 24 hours and 2.5 g per ml at 48 hours; concentrations above 8µg per ml are maintained by daily maintenance dose of 1 g. Comparable concentrations are achieved with equivalent intravenous dose. The plasma elimination half life of Tinidazole is 12 to 14 hours. Tinidazole is widely distributed and concentrations similar to those in plasma have been achieved in bile, breast milk, cerebrospinal fluid, saliva, and a variety of body tissues, it crosses the placenta readily. Only 12% is reported to be bound to plasma proteins. An active hydroxyl metabolite has been identified. Unchanged drug and metabolites are excreted in the urine and to lesser extent in the faeces.

 

WARNING: POTENTIAL RISK FOR CARCINOGENICITY

Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent. Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects.

 

STORAGE

Store in an airtight container, protected from heat and light.

KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN

 

Manufactured by

GREENFIELD PHARMACEUTICAL (JIANG SU) CO., LTD.

NO.38, TAI JIU ROAD, TAI ZHOU, JIANG SU PROVINCE, P.R.CHINA

 

Marketed by

BAKAN GIZO NIG. LTD.

(PHARMACEUTICAL DIVIDION)