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AFM-Plus
Fluorometholone + Gentamicin
AFM-Plus
Fluorometholone + Gentamicin
Indications
Ocular inflammation
Indication detailsView
Inflammation associated with infections in the anterior segment of the eye due to bacteria susceptible to Gentamicin it is also indicated in postoperative infection.
Therapeutic classView
Ophthalmic steroid - antibiotic combined preparations
PharmacologyView
Gentamicin belongs to the group of aminoglycoside antibiotics. It covers a broad spectrum of gram-positive and gram-negative pathogens, including Pseudomonas aeruginosa, Staphylococci, Haemophilus influenzae H. aegypticus, Klebsiella, Enterobacteria, Proteus, Escherichia coli, Shigella and Salmonella. It inhibits specifically bacterial protein synthesis. Fluorometholone is a synthetic fluorinated corticosteroid possessing anti-inflammatory properties. The combination brings concomitantly the bacterial treatment or prophylaxis and the anti-inflammatory effect. In addition, the presence of gentamicin protects from a risk of potential aggravation of a bacterial infection due to the steroid.
DosageView
Sterile Ophthalmic Suspension:
- Bacterial infection: The dosage depends on the severity of the disease. The application of 1 drop 5 times daily into the conjunctival sac of the affected eye is recommended. In severe cases the dosage can be increased up to 1 drop per hour for 1 to 2 days.
- Ocular postoperative infection: 1 drop 4 times daily into the conjunctival sac for 1 week. Then a reduced application frequency is recommended for the remaining part of the treatment.
- Bacterial infection: Apply 3-4 times daily into the affected eye.
- Ocular postoperative infection: To support the therapy with Ophthalmic Suspension during the night apply ointment before retiring.
Side effectsView
A transient burning sensation may occur after instillation. Rare: Hypersensitivity reactions including eczema of the eyelid and puncture keratitis. Prolonged use of topical steroids may delay wound healing, increase of IOP, develop cataract and cause thinning of cornea & sclera.
ContraindicationsView
- Hypersensitivity to any of the components. Injuries and ulceration of the cornea. Viral infections (e.g. Herpes simplex, Vaccinia) or mycosis.
- Eye tuberculosis.
- Glaucoma.
PrecautionsView
- Steroids can mask, activate or aggravate ocular infections.
- Long-term treatment with steroid may enhance thinning of cornea and sclera and rarely perforation of the cornea has been reported.
- In case no improvement is observed after 7-8 days of treatment, other therapeutical means should be considered.
- Patients experiencing blurred vision after application of the product, particularly the ointment, should refrain from driving vehicles or operating machinery.
- Contact lenses should be removed before each application.
Pregnancy & lactationView
No controlled studies in humans are available. Administration during pregnancy and lactation is therefore not recommended, except for compelling reasons.
StorageView
Store in a cool and dry place, protect from light. Do not use longer than 30 days after first opening. Keep out of reach of children.
AFM-Plus
Fluorometholone + Gentamicin
AFM-Plus
Fluorometholone + Gentamicin
Indications
Ocular inflammation
Indication detailsView
Inflammation associated with infections in the anterior segment of the eye due to bacteria susceptible to Gentamicin it is also indicated in postoperative infection.
Therapeutic classView
Ophthalmic steroid - antibiotic combined preparations
PharmacologyView
Gentamicin belongs to the group of aminoglycoside antibiotics. It covers a broad spectrum of gram-positive and gram-negative pathogens, including Pseudomonas aeruginosa, Staphylococci, Haemophilus influenzae H. aegypticus, Klebsiella, Enterobacteria, Proteus, Escherichia coli, Shigella and Salmonella. It inhibits specifically bacterial protein synthesis. Fluorometholone is a synthetic fluorinated corticosteroid possessing anti-inflammatory properties. The combination brings concomitantly the bacterial treatment or prophylaxis and the anti-inflammatory effect. In addition, the presence of gentamicin protects from a risk of potential aggravation of a bacterial infection due to the steroid.
DosageView
Sterile Ophthalmic Suspension:
- Bacterial infection: The dosage depends on the severity of the disease. The application of 1 drop 5 times daily into the conjunctival sac of the affected eye is recommended. In severe cases the dosage can be increased up to 1 drop per hour for 1 to 2 days.
- Ocular postoperative infection: 1 drop 4 times daily into the conjunctival sac for 1 week. Then a reduced application frequency is recommended for the remaining part of the treatment.
- Bacterial infection: Apply 3-4 times daily into the affected eye.
- Ocular postoperative infection: To support the therapy with Ophthalmic Suspension during the night apply ointment before retiring.
Side effectsView
A transient burning sensation may occur after instillation. Rare: Hypersensitivity reactions including eczema of the eyelid and puncture keratitis. Prolonged use of topical steroids may delay wound healing, increase of IOP, develop cataract and cause thinning of cornea & sclera.
ContraindicationsView
- Hypersensitivity to any of the components. Injuries and ulceration of the cornea. Viral infections (e.g. Herpes simplex, Vaccinia) or mycosis.
- Eye tuberculosis.
- Glaucoma.
PrecautionsView
- Steroids can mask, activate or aggravate ocular infections.
- Long-term treatment with steroid may enhance thinning of cornea and sclera and rarely perforation of the cornea has been reported.
- In case no improvement is observed after 7-8 days of treatment, other therapeutical means should be considered.
- Patients experiencing blurred vision after application of the product, particularly the ointment, should refrain from driving vehicles or operating machinery.
- Contact lenses should be removed before each application.
Pregnancy & lactationView
No controlled studies in humans are available. Administration during pregnancy and lactation is therefore not recommended, except for compelling reasons.
StorageView
Store in a cool and dry place, protect from light. Do not use longer than 30 days after first opening. Keep out of reach of children.
AFM-T
Fluorometholone + Tetrahydrozoline
AFM-T
Fluorometholone + Tetrahydrozoline
Indications
Scleritis
Indication detailsView
This eye drops is indicated in acute allergic, noninfectious conjunctivitis & keratitis, severe swelling & hyperaemia, noninfectious inflammation of the anterior segment of the eye (including anterior uveitis, episcleritis & scleritis) and post-operative conditions.
Therapeutic classView
Ophthalmic Steroid preparations
PharmacologyView
Fluorometholone is thought to act by the induction of phospholipase A2 inhibitory proteins which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. On the other hand, Tetrahydrozoline is an alpha agonist which constricts the conjunctival blood vessels and thereby relieves the redness of the eye.
DosageView
Use in adult: Instill 1 drop into the conjunctival sac 2-3 times daily. The dose may be increased for severe and adult patient to 1 drop hourly for first one to two days.
Use in children: Safety & effectiveness in children below 2 years of age have not been established.
Use in children: Safety & effectiveness in children below 2 years of age have not been established.
Side effectsView
Mild burning sensation, reversible increase in intraocular pressure, reactive hyperemia, cataract & corneal defects, glaucoma, systemic effects (chronic use).
ContraindicationsView
It is contraindicated in infectious conjunctivitis or keratitis, injuries or ulcerous processes of the cornea, glaucoma, diseases associated with stromal damage of the cornea or sclera & dry eyes.
PrecautionsView
Avoid prolonged use. This preparation should be used after a careful risk benefit evaluation in case of patients with severe blood circulation diseases, metabolic disturbances, under treatment with MAOIs & other potentially hypertensive drugs, history of cataract, herpes simplex infection, rhinitis sicca.
Pregnancy & lactationView
There are no adequate and well-controlled studies of Fluorometholone & Tetrahydrozoline in pregnancy or while breast-feeding. Therefore, this combination should be used during pregnancy only if the potential benefits justify the potential risk to the fetus.
Overdose effectsView
When the product is used as directed, there is almost no likelihood of an overdose. No information on overdosage with fluorometholone is available. Overdosage with fluorometholone is unlikely to cause acute problems. The symptoms of acute overdosage with tetryzoline are CNS, cardiac and psychiatric disturbances, mydriasis, cyanosis and fever. CNS functions may be inhibited under certain circumstances.
The following measures are possible in case of accidental ingestion and the occurrence of symptoms of intoxication: administration of activated charcoal, gastric lavage, artificial ventilation with oxygen, use of phentolamine to lower blood pressure (5 mg in saline solution, given i.v.). Vasopressors are contraindicated. Antipyretic and anticonvulsive therapy can be administered as necessary.
The following measures are possible in case of accidental ingestion and the occurrence of symptoms of intoxication: administration of activated charcoal, gastric lavage, artificial ventilation with oxygen, use of phentolamine to lower blood pressure (5 mg in saline solution, given i.v.). Vasopressors are contraindicated. Antipyretic and anticonvulsive therapy can be administered as necessary.
StorageView
Should not be used after the date marked "EXP" on the pack. This must be kept out of the reach and sight of children.
AH
Albendazole
AH
Albendazole
Indications
Worm infections
Indication detailsView
Albendazole is indicated in single and mixed infestations of-
- Hookworm (Ancylostoma, Necator)
- Roundworm (Ascaris)
- Threadworm (Enterobius)
- Whipworm (Trichuris)
- Strongyloides
- Tapeworm
- Opisthorchi
- Hydatid.
Therapeutic classView
Anthelmintic
PharmacologyView
Albendazole is a broad spectrum anthelmintic. Albendazole exhibits vermicidal, ovicidal and larvicidal activities. The drug is thought to exert its anthelmintic effect by blocking glucose uptake in the susceptible helminths, thereby depleting the energy level until it becomes inadequate for survival. Immobilization is followed by the parasite. These events may be a consequence of the binding and subsequent inhibition of parasite tubulin polymerization by Albendazole and its metabolites, although the drug also binds to human tubulin. Albendazole is extensively metabolized, probably in the liver. Albendazole is poorly absorbed from the gastrointestinal tract but rapidly undergoes extensive first-pass metabolism. The principal metabolite albendazole sulphoxide has anthelmintic activity and a plasma half-life of about 8.5 hrs. It is excreted in the urine together with other metabolites.
DosageView
Adults & children over 2 years:
Children under 1 year: Not recommended.
In Hydatid disease (Echinococcosis):
- 400 mg (1 tablet or 10 ml suspension) as a single dose in cases of Enterobius vermicularis, Trichuris trichiura, Ascaris lumbricoides, Ancylostoma duodenale and Necator americanus.
- In cases of strongyloidiasis or taeniasis, 400 mg (1 tablet or 10 ml suspension) daily should be given for 3 consecutive days. If the patient is not cured on follow-up after three weeks, a second course of treatment is indicated.
Children under 1 year: Not recommended.
In Hydatid disease (Echinococcosis):
- Albendazole is given by mouth with meals in a dose of 400 mg twice daily for 28 days for patients weighing over 60 kg.
- A dose of 15 mg/kg body weight daily in two divided doses (to a maximum total daily dose of 800 mg) is used for patients weighing less than 60 kg.
- For cystic echinococcosis, the 28 days course may be repeated after 14 days without treatment, to a total of 3 treatment cycles.
- For alveolar echinococcosis, cycles of 28 days of treatment followed by 14 days without treatment, may need to continue for months or years.
- In giardiasis, 400 mg (1 tablet or 10 ml suspension) once daily for five days is used.
Side effectsView
Gastrointestinal disturbances, headache, dizziness, changes in liver enzymes, rarely reversible alopecia; rash, fever, blood disorders including leucopenia and pancytopenia reported; allergic shock if cyst leakage; convulsion and meningism in cerebral disease.
ContraindicationsView
Neonates: Albendazole is not normally used in neonates.
Children: Reduction of the dose from 400 mg to 200 mg may be indicated in children weighing less than 10 kg but there are no grounds for a general reduction in dosage to children.
Pregnant woman: Albendazole should not be given during pregnancy or women thought to be pregnant. No information is available on placental transfer.
Concurrent disease: There is no evidence to suggest that dose should be altered in renal, hepatic or cardiac failure.
Children: Reduction of the dose from 400 mg to 200 mg may be indicated in children weighing less than 10 kg but there are no grounds for a general reduction in dosage to children.
Pregnant woman: Albendazole should not be given during pregnancy or women thought to be pregnant. No information is available on placental transfer.
Concurrent disease: There is no evidence to suggest that dose should be altered in renal, hepatic or cardiac failure.
PrecautionsView
Blood counts and liver function tests before treatment and twice during each cycle; breastfeeding; exclude pregnancy before starting treatment. Albendazole should only be used in the treatment of Echinococcosis if there is constant medical supervision with regular monitoring of serum-transaminase concentrations and of leucocyte and platelet counts
InteractionsView
No interaction involving Albendazole, either pharmacodynamic or pharmacokinetic, has been reported.
Pregnancy & lactationView
US FDA Pregnancy category of Albendazole is C. So, Albendazole should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep in a dry place, away from light and heat. Keep out of the reach of children.
AH
Albendazole
AH
Albendazole
Indications
Worm infections
Indication detailsView
Albendazole is indicated in single and mixed infestations of-
- Hookworm (Ancylostoma, Necator)
- Roundworm (Ascaris)
- Threadworm (Enterobius)
- Whipworm (Trichuris)
- Strongyloides
- Tapeworm
- Opisthorchi
- Hydatid.
Therapeutic classView
Anthelmintic
PharmacologyView
Albendazole is a broad spectrum anthelmintic. Albendazole exhibits vermicidal, ovicidal and larvicidal activities. The drug is thought to exert its anthelmintic effect by blocking glucose uptake in the susceptible helminths, thereby depleting the energy level until it becomes inadequate for survival. Immobilization is followed by the parasite. These events may be a consequence of the binding and subsequent inhibition of parasite tubulin polymerization by Albendazole and its metabolites, although the drug also binds to human tubulin. Albendazole is extensively metabolized, probably in the liver. Albendazole is poorly absorbed from the gastrointestinal tract but rapidly undergoes extensive first-pass metabolism. The principal metabolite albendazole sulphoxide has anthelmintic activity and a plasma half-life of about 8.5 hrs. It is excreted in the urine together with other metabolites.
DosageView
Adults & children over 2 years:
Children under 1 year: Not recommended.
In Hydatid disease (Echinococcosis):
- 400 mg (1 tablet or 10 ml suspension) as a single dose in cases of Enterobius vermicularis, Trichuris trichiura, Ascaris lumbricoides, Ancylostoma duodenale and Necator americanus.
- In cases of strongyloidiasis or taeniasis, 400 mg (1 tablet or 10 ml suspension) daily should be given for 3 consecutive days. If the patient is not cured on follow-up after three weeks, a second course of treatment is indicated.
Children under 1 year: Not recommended.
In Hydatid disease (Echinococcosis):
- Albendazole is given by mouth with meals in a dose of 400 mg twice daily for 28 days for patients weighing over 60 kg.
- A dose of 15 mg/kg body weight daily in two divided doses (to a maximum total daily dose of 800 mg) is used for patients weighing less than 60 kg.
- For cystic echinococcosis, the 28 days course may be repeated after 14 days without treatment, to a total of 3 treatment cycles.
- For alveolar echinococcosis, cycles of 28 days of treatment followed by 14 days without treatment, may need to continue for months or years.
- In giardiasis, 400 mg (1 tablet or 10 ml suspension) once daily for five days is used.
Side effectsView
Gastrointestinal disturbances, headache, dizziness, changes in liver enzymes, rarely reversible alopecia; rash, fever, blood disorders including leucopenia and pancytopenia reported; allergic shock if cyst leakage; convulsion and meningism in cerebral disease.
ContraindicationsView
Neonates: Albendazole is not normally used in neonates.
Children: Reduction of the dose from 400 mg to 200 mg may be indicated in children weighing less than 10 kg but there are no grounds for a general reduction in dosage to children.
Pregnant woman: Albendazole should not be given during pregnancy or women thought to be pregnant. No information is available on placental transfer.
Concurrent disease: There is no evidence to suggest that dose should be altered in renal, hepatic or cardiac failure.
Children: Reduction of the dose from 400 mg to 200 mg may be indicated in children weighing less than 10 kg but there are no grounds for a general reduction in dosage to children.
Pregnant woman: Albendazole should not be given during pregnancy or women thought to be pregnant. No information is available on placental transfer.
Concurrent disease: There is no evidence to suggest that dose should be altered in renal, hepatic or cardiac failure.
PrecautionsView
Blood counts and liver function tests before treatment and twice during each cycle; breastfeeding; exclude pregnancy before starting treatment. Albendazole should only be used in the treatment of Echinococcosis if there is constant medical supervision with regular monitoring of serum-transaminase concentrations and of leucocyte and platelet counts
InteractionsView
No interaction involving Albendazole, either pharmacodynamic or pharmacokinetic, has been reported.
Pregnancy & lactationView
US FDA Pregnancy category of Albendazole is C. So, Albendazole should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep in a dry place, away from light and heat. Keep out of the reach of children.
AL-DS
Albendazole
AL-DS
Albendazole
Indications
Worm infections
Indication detailsView
Albendazole is indicated in single and mixed infestations of-
- Hookworm (Ancylostoma, Necator)
- Roundworm (Ascaris)
- Threadworm (Enterobius)
- Whipworm (Trichuris)
- Strongyloides
- Tapeworm
- Opisthorchi
- Hydatid.
Therapeutic classView
Anthelmintic
PharmacologyView
Albendazole is a broad spectrum anthelmintic. Albendazole exhibits vermicidal, ovicidal and larvicidal activities. The drug is thought to exert its anthelmintic effect by blocking glucose uptake in the susceptible helminths, thereby depleting the energy level until it becomes inadequate for survival. Immobilization is followed by the parasite. These events may be a consequence of the binding and subsequent inhibition of parasite tubulin polymerization by Albendazole and its metabolites, although the drug also binds to human tubulin. Albendazole is extensively metabolized, probably in the liver. Albendazole is poorly absorbed from the gastrointestinal tract but rapidly undergoes extensive first-pass metabolism. The principal metabolite albendazole sulphoxide has anthelmintic activity and a plasma half-life of about 8.5 hrs. It is excreted in the urine together with other metabolites.
DosageView
Adults & children over 2 years:
Children under 1 year: Not recommended.
In Hydatid disease (Echinococcosis):
- 400 mg (1 tablet or 10 ml suspension) as a single dose in cases of Enterobius vermicularis, Trichuris trichiura, Ascaris lumbricoides, Ancylostoma duodenale and Necator americanus.
- In cases of strongyloidiasis or taeniasis, 400 mg (1 tablet or 10 ml suspension) daily should be given for 3 consecutive days. If the patient is not cured on follow-up after three weeks, a second course of treatment is indicated.
Children under 1 year: Not recommended.
In Hydatid disease (Echinococcosis):
- Albendazole is given by mouth with meals in a dose of 400 mg twice daily for 28 days for patients weighing over 60 kg.
- A dose of 15 mg/kg body weight daily in two divided doses (to a maximum total daily dose of 800 mg) is used for patients weighing less than 60 kg.
- For cystic echinococcosis, the 28 days course may be repeated after 14 days without treatment, to a total of 3 treatment cycles.
- For alveolar echinococcosis, cycles of 28 days of treatment followed by 14 days without treatment, may need to continue for months or years.
- In giardiasis, 400 mg (1 tablet or 10 ml suspension) once daily for five days is used.
Side effectsView
Gastrointestinal disturbances, headache, dizziness, changes in liver enzymes, rarely reversible alopecia; rash, fever, blood disorders including leucopenia and pancytopenia reported; allergic shock if cyst leakage; convulsion and meningism in cerebral disease.
ContraindicationsView
Neonates: Albendazole is not normally used in neonates.
Children: Reduction of the dose from 400 mg to 200 mg may be indicated in children weighing less than 10 kg but there are no grounds for a general reduction in dosage to children.
Pregnant woman: Albendazole should not be given during pregnancy or women thought to be pregnant. No information is available on placental transfer.
Concurrent disease: There is no evidence to suggest that dose should be altered in renal, hepatic or cardiac failure.
Children: Reduction of the dose from 400 mg to 200 mg may be indicated in children weighing less than 10 kg but there are no grounds for a general reduction in dosage to children.
Pregnant woman: Albendazole should not be given during pregnancy or women thought to be pregnant. No information is available on placental transfer.
Concurrent disease: There is no evidence to suggest that dose should be altered in renal, hepatic or cardiac failure.
PrecautionsView
Blood counts and liver function tests before treatment and twice during each cycle; breastfeeding; exclude pregnancy before starting treatment. Albendazole should only be used in the treatment of Echinococcosis if there is constant medical supervision with regular monitoring of serum-transaminase concentrations and of leucocyte and platelet counts
InteractionsView
No interaction involving Albendazole, either pharmacodynamic or pharmacokinetic, has been reported.
Pregnancy & lactationView
US FDA Pregnancy category of Albendazole is C. So, Albendazole should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep in a dry place, away from light and heat. Keep out of the reach of children.
AM
Azithromycin Dihydrate
AM
Azithromycin Dihydrate
Indication detailsView
Azithromycin is indicated for infections (caused by susceptible organisms) in lower respiratory tract infections including bronchitis and pneumonia, in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis, in otitis media, and in skin and soft tissue infections. In sexually transmitted diseases in men and women, Azithromycin is indicated in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.
PharmacologyView
Azithromycin is acid-stable and can therefore be taken orally with no need of protection from gastric acids. It is readily absorbed; its absorption is greater on an empty stomach. Time to peak concentration in adults is 2.1 to 3.2 hours for oral dosage forms. Due to the high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations of azithromycin are released. The concentration of azithromycin in the tissues can be over 50 times higher than in plasma. This is due to ion trapping and the high lipid solubility.
Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.
Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:
Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.
Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:
- Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
- Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
- Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis , Mycoplasma pneumoniae , Betalactamase production should have no effect on azithromycin activity.
- Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C,F,G), Viridans group streptococci
- Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila
- Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia
DosageView
Oral-
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.
Children:
Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.
Children:
- 10 mg/kg body weight once daily for 3 days for child over 6 months
- 200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
- 300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg.
- In typhoid fever, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given.
Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:
- 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
- The recommended dose of Azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
- Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.
AdministrationView
Reconstitution procedure of suspension-
- Step 01: Shake the bottle well to loosen the powder.
- Step 02: Add boiled and cooled water up to the water mark of the bottle label.
- Step 03: Shake until powder is completely mixed with water.
Side effectsView
Azithromycin is well tolerated with a low incidence of side effects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhoea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy.
ContraindicationsView
Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.
PrecautionsView
As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended. No dose adjustment is needed in patients with renal impairment.
InteractionsView
Azithromycin absorption is reduced in presence of food and antacid. In patients receiving ergot alkaloids Azithromycin should be avoided because of the possibility of ergotism resulting from interaction of Azithromycin with the cytochrome P-450 system. As macrolides increase the plasma concentration of digoxin and cyclosporin, caution should be exercised while co-administration. There have been no drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone or Cimetidine.
Pregnancy & lactationView
Pregnancy Category of Azithromycin is B. Animal reproduction studies have demonstrated that Azithromycin has no evidence of harm to the fetus. There are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if adequate alternatives are not available. It is not known whether Azithromycin is secreted in breast milk. So, caution should be exercised when Azithromycin is administered to nursing women.
Overdose effectsView
There is no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
AM
Azithromycin Dihydrate
AM
Azithromycin Dihydrate
Indication detailsView
Azithromycin is indicated for infections (caused by susceptible organisms) in lower respiratory tract infections including bronchitis and pneumonia, in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis, in otitis media, and in skin and soft tissue infections. In sexually transmitted diseases in men and women, Azithromycin is indicated in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.
PharmacologyView
Azithromycin is acid-stable and can therefore be taken orally with no need of protection from gastric acids. It is readily absorbed; its absorption is greater on an empty stomach. Time to peak concentration in adults is 2.1 to 3.2 hours for oral dosage forms. Due to the high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations of azithromycin are released. The concentration of azithromycin in the tissues can be over 50 times higher than in plasma. This is due to ion trapping and the high lipid solubility.
Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.
Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:
Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.
Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:
- Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
- Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
- Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis , Mycoplasma pneumoniae , Betalactamase production should have no effect on azithromycin activity.
- Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C,F,G), Viridans group streptococci
- Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila
- Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia
DosageView
Oral-
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.
Children:
Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.
Children:
- 10 mg/kg body weight once daily for 3 days for child over 6 months
- 200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
- 300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg.
- In typhoid fever, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given.
Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:
- 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
- The recommended dose of Azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
- Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.
AdministrationView
Reconstitution procedure of suspension-
- Step 01: Shake the bottle well to loosen the powder.
- Step 02: Add boiled and cooled water up to the water mark of the bottle label.
- Step 03: Shake until powder is completely mixed with water.
Side effectsView
Azithromycin is well tolerated with a low incidence of side effects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhoea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy.
ContraindicationsView
Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.
PrecautionsView
As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended. No dose adjustment is needed in patients with renal impairment.
InteractionsView
Azithromycin absorption is reduced in presence of food and antacid. In patients receiving ergot alkaloids Azithromycin should be avoided because of the possibility of ergotism resulting from interaction of Azithromycin with the cytochrome P-450 system. As macrolides increase the plasma concentration of digoxin and cyclosporin, caution should be exercised while co-administration. There have been no drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone or Cimetidine.
Pregnancy & lactationView
Pregnancy Category of Azithromycin is B. Animal reproduction studies have demonstrated that Azithromycin has no evidence of harm to the fetus. There are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if adequate alternatives are not available. It is not known whether Azithromycin is secreted in breast milk. So, caution should be exercised when Azithromycin is administered to nursing women.
Overdose effectsView
There is no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
AMX
Amoxicillin Trihydrate
AMX
Amoxicillin Trihydrate
Indications
Skin and skin sructure infections
Indication detailsView
Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
- Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
- Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
- Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
- Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
- Venereal disease (i.e. acute uncomplicated gonorrhoea)
- In dental abscess, it is used as short-term therapy.
- It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
Therapeutic classView
Broad spectrum penicillins
PharmacologyView
Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
DosageView
Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
- Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
- Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
- Pneumonia: Recommended dose is 500-1000 mg three times daily.
- Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
- Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
- Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
- In renal impairment: it may be necessary to reduce the total daily dosage.
AdministrationView
Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
Side effectsView
Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
ContraindicationsView
Amoxicillin is contraindicated in penicillin hypersensitive patients.
PrecautionsView
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
InteractionsView
Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Pregnancy & lactationView
US FDA pregnancy category of Amoxicillin is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
ReconstitutionView
Amoxycillin 500 mg Injection:
- Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
- Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
AMX
Amoxicillin Trihydrate
AMX
Amoxicillin Trihydrate
Indications
Skin and skin sructure infections
Indication detailsView
Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
- Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
- Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
- Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
- Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
- Venereal disease (i.e. acute uncomplicated gonorrhoea)
- In dental abscess, it is used as short-term therapy.
- It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
Therapeutic classView
Broad spectrum penicillins
PharmacologyView
Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
DosageView
Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
- Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
- Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
- Pneumonia: Recommended dose is 500-1000 mg three times daily.
- Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
- Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
- Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
- In renal impairment: it may be necessary to reduce the total daily dosage.
AdministrationView
Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
Side effectsView
Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
ContraindicationsView
Amoxicillin is contraindicated in penicillin hypersensitive patients.
PrecautionsView
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
InteractionsView
Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Pregnancy & lactationView
US FDA pregnancy category of Amoxicillin is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
ReconstitutionView
Amoxycillin 500 mg Injection:
- Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
- Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
AMX
Amoxicillin Trihydrate
AMX
Amoxicillin Trihydrate
Indications
Skin and skin sructure infections
Indication detailsView
Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
- Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
- Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
- Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
- Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
- Venereal disease (i.e. acute uncomplicated gonorrhoea)
- In dental abscess, it is used as short-term therapy.
- It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
Therapeutic classView
Broad spectrum penicillins
PharmacologyView
Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
DosageView
Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
- Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
- Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
- Pneumonia: Recommended dose is 500-1000 mg three times daily.
- Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
- Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
- Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
- In renal impairment: it may be necessary to reduce the total daily dosage.
AdministrationView
Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
Side effectsView
Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
ContraindicationsView
Amoxicillin is contraindicated in penicillin hypersensitive patients.
PrecautionsView
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
InteractionsView
Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Pregnancy & lactationView
US FDA pregnancy category of Amoxicillin is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
ReconstitutionView
Amoxycillin 500 mg Injection:
- Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
- Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
AMX DS
Amoxicillin Trihydrate
AMX DS
Amoxicillin Trihydrate
Indications
Skin and skin sructure infections
Indication detailsView
Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
- Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
- Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
- Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
- Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
- Venereal disease (i.e. acute uncomplicated gonorrhoea)
- In dental abscess, it is used as short-term therapy.
- It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
Therapeutic classView
Broad spectrum penicillins
PharmacologyView
Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
DosageView
Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
- Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
- Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
- Pneumonia: Recommended dose is 500-1000 mg three times daily.
- Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
- Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
- Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
- In renal impairment: it may be necessary to reduce the total daily dosage.
AdministrationView
Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
Side effectsView
Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
ContraindicationsView
Amoxicillin is contraindicated in penicillin hypersensitive patients.
PrecautionsView
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
InteractionsView
Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Pregnancy & lactationView
US FDA pregnancy category of Amoxicillin is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
ReconstitutionView
Amoxycillin 500 mg Injection:
- Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
- Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
APN
Sodium Chloride + Dextrose
APN
Sodium Chloride + Dextrose
Indications
Fluid and electrolyte imbalance
Indication detailsView
This solution is indicated when there is combined water and sodium depletion. It provides Dextrose as a nutrient in a suitable medium of Sodium Chloride which is isotonic to body fluid, or it may also be employed as a source of isotonic Sodium Chloride or both. It is usually used in the maintenance and replacement of fluid, electrolyte and carbohydrate in patients who are unable to take fluid and nutrients by mouth e.g. in case of persistent vomiting, during and after surgery, shock or accidents.
Therapeutic classView
Intravenous fluid preparations, Parenteral nutritional preparations
DosageView
Dose is variable. It depends on the clinical condition, age and body surface area of the patients.
AdministrationView
- Check infusion set and infusion solution prior to use.
- Pull moderately to tear off the protective cover of the Eurocap.
- Hold lightly the Eurocap but not the bottle body.
- Open the flow regulator fully and hold the giving set on the top white area, but not the memorane venting region.
- Insert the spike of the administration set to the Eurocap and fit the connector of the administration set firmly to the needle.
- Gradually allow the fluid to flow down to the needletip and close.
- Remove the protective cover of the needle.
- Locate the venpuncture site and clean the site with an antiseptic solution, and then insert the needle.
- Securely tape the puncture site.
- Securely tape the wings and tubing
- Start infusion while adjusting drip speed.
Side effectsView
Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
ContraindicationsView
Do not take this medicine and tell your doctor if: Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.
PrecautionsView
As the preparation contains Sodium Chloride, it should be administered with caution to patients with congestive heart failure, peripheral or pulmonary oedema, impaired renal function or pre-eclampsia. Serum glucose concentration should also be carefully monitored and concurrent use of insulin may be needed in case of diabetic patients. Infusion of fluid should be immediately discontinued if rigor arises for any reason during the process. Do not use if the solution is cloudy, contains particles, or after expiry date.
Pregnancy & lactationView
FDA pregnancy category C. It is not known whether dextrose 5% in water will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether dextrose 5% in water passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
APT
Clopidogrel Bisulphate
APT
Clopidogrel Bisulphate
Indications
Unstable angina
Indication detailsView
Acute Coronary Syndrome (ACS): It is indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)]. It is indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI).
Recent MI, recent Stroke, or established Peripheral Arterial Disease: In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke it is indicated to reduce the rate of MI and stroke.
Recent MI, recent Stroke, or established Peripheral Arterial Disease: In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke it is indicated to reduce the rate of MI and stroke.
Therapeutic classView
Anti-platelet drugs
PharmacologyView
Clopidogrel is a prodrug. It inhibits platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets. Dose-dependent inhibition of platelet aggregation can be seen 2 hours after single oral doses. Repeated doses of 75 mg per day inhibit ADP-induced platelet aggregation on the first day, and inhibition reaches steady state between Day 3 and Day 7.
DosageView
Acute Coronary Syndrome: In patients who need an antiplatelet effect within hours, initiate clopidogrel with a single 300 mg (4 tablets) oral loading dose and then continue at 75 mg once daily. Initiating it without a loading dose will delay establishment of an antiplatelet effect by several days.
Recent MI, Recent Stroke, or Established Peripheral Arterial Disease: 75 mg once daily orally without a loading dose.
It is given orally with or without food.
Recent MI, Recent Stroke, or Established Peripheral Arterial Disease: 75 mg once daily orally without a loading dose.
It is given orally with or without food.
Side effectsView
Clopidogrel is generally well tolerated drug.
- Common side effects: Bleeding, Diarrhoea, gastrointestinal discomfort, haemorrhage, Skin reactions.
- Rare side effects: Acquired haemophilia, anaemia, angioedema, arthralgia, arthritis, bone marrow disorders.
ContraindicationsView
Clopidogrel is contraindicated in the following conditions: Hypersensitivity to the drug substance or any component of the product. Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
PrecautionsView
- As it is a prodrug, so metabolism to its active metabolite is impaired by genetic variations in CYP2C19 (poor metabolizer) and by the drugs that inhibit CYP2C19 such as Omeprazole and Esomeprazole. Concomitant use with these drugs and in CYP2C19 poor metaboliser may reduce the antiplatelet activity of Clopidogrel.
- As it inhibits platelet aggregation for the lifetime of the platelet (7-10 days), risk of bleeding may increase. To restore hemostasis, platelet transfusions within 4 hours of the loading dose or 2 hours of the maintenance dose may be less effective.
- Discontinuation of Clopidogrel increases the risk of cardiovascular events. Discontinue 5 days prior to elective surgery that has a major risk of bleeding. Resume Clopidogrel as soon as hemostasis is achieved.
- Thrombotic Thrombocytopenic Purpura (TTP) has been reported that requires urgent treatment including plasmapheresis (plasma exchange).
- Hypersensitivity including rash, angioedema or hematologic reaction has been reported in patients receiving clopidogrel or history of hypersensitivity to other thienopyridines.
InteractionsView
- NSAIDs, warfarin, selective serotonin and serotonin norepinephrine reuptake inhibitors (SSRIs, SNRIs): Increases risk of bleeding
- CYP2C19 inhibitors (omeprazole or esomeprazole): Avoid concomitant use of omeprazole or esomeprazole
- Repaglinide (CYP2C8 substrates): Avoid concomitant use of Clopidogrel with Repaglinide as it increases plasma concentrations of Repaglinide
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed. It is unknown whether clopidogrel is excreted in human breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Safety and effectiveness in pediatric populations have not been established. No dosage adjustment is necessary in elderly patients.
Overdose effectsView
Overdose following clopidogrel administration may lead to bleeding complications. Based on biological plausibility, platelet transfusion may restore clotting ability.
StorageView
Keep below 30°C temperature in a dry place. Protected from light. Do not freeze. Keep out of the reach of children.
ARB
Candesartan Cilexetil
ARB
Candesartan Cilexetil
Indications
Hypertension
Indication detailsView
Candesartan Cilexetil is indicated for hypertension, heart failure with impaired left ventricular systolic function.
Therapeutic classView
Angiotensin-ll receptor blocker
PharmacologyView
Candesartan Cilexetil is an ester prodrug that is hydrolysed in the body to the active form Candesartan during absorption from the gastro-intestinal tract. Candesartan is angiotensin II receptor (type AT1) antagonist. Candesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues (eg, vascular smooth muscle, adrenal gland).
DosageView
Hypertention: initially 8 mg (hepatic impairment 2 mg, renal impairment or intravascular volume depletion 4 mg) once daily, increased if necessary at intervals of 4 weeks to max 32 mg once daily; usual maintenance dose 8 mg once daily.
Heart failure: initially 4 mg once daily, increased at intervals of at least 2 weeks to target dose of 32 mg once daily or to max tolerated dose.
Heart failure: initially 4 mg once daily, increased at intervals of at least 2 weeks to target dose of 32 mg once daily or to max tolerated dose.
Side effectsView
Side-effects are usually mild. Symptomatic hypotension including dizziness may occur, particularly in patients with intravascular volume depletion (e.g. those taking high dose diuretics). Hyperkalemia occurs occassionally; angioedema has also been reported with some angiotension II receptor antagonist. Also vertigo, headache; rarely hepatitis, blood disorders, hyponatraemia, back pain, arthralgia, myalgia, rash, urticaria, pruritous.
ContraindicationsView
Hypersensitivity to any component of this product. Pregnancy, breast-feeding, cholestasis.
PrecautionsView
Candesartan should be used with caution in renal artery stenosis, aortic or mitral valve stenosis and in obstructive hypertropic cardiomyopathy. Monitoring of plasma-potassium concentration is advised, particularly in the elderly and in patients with renal impairment; lower initial doses may be appropriate in these patients.
InteractionsView
No significant drug interactions have been reported in studies of Candesartan Cilexetil given with other drugs such as glyburide, nifedipine, digoxin, warfarin, hydrochlorothiazide and oral contraceptives in healthy volunteers. Because candesartan is not metabolised by the cytochrome P-450 system and has no effects on P-450 enzymes, interactions with drugs that inhibit, or are metabolised by, those enzymes could not be expected.
Pregnancy & lactationView
When pregnancy is detected, Candesartan Cilexetil should be discontinued as soon as possible. It should be used in lactation.
Pediatric usageView
Use in pediatric: Safety and effectiveness in pediatric patients have not been established.
StorageView
Store in a cool & dry place. Protect from light and moisture
ASP
Aceclofenac
ASP
Aceclofenac
Indications
Spondylitis
Indication detailsView
Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, toothache, trauma and lumbago.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.
DosageView
Extended release tablet: The recommended dose in adults is one 200 mg Aceclofenac tablet daily or as prescribed by the physician.
Film coated tablet: The recommended dose in adults is 100 mg, twice daily.
Side effectsView
Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.
ContraindicationsView
Aceclofenac is contraindicated in patients with known hypersensitivity to it or in whom aspirin or NSAIDs precipitate attacks of asthma.
PrecautionsView
Caution should be exercised to patients with active or suspected peptic ulcer or gastro-intestinal bleeding moderate to severe hepatic impairment and cardiac or renal impairment. Caution should also be exercised in patients suffering from dizziness or urticaria.
InteractionsView
No significant drug interactions has not been observed but close monitoring of patients is required when it is used with:
- Lithium and Digoxin: may increase plasma concentration of lithium and digoxin.
- Diuretics: may interact the activity of diuretics.
- Anticoagulants: may enhance the activity of anticoagulant.
- Methotrexate: may increase the plasma level of methotrexate.
Pregnancy & lactationView
The use of Aceclofenac should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
Pediatric usageView
There are no clinical data on the use of Aceclofenac in children.
StorageView
keep in a dry place away from light and heat. Keep out of the reach of children.
ATP
Paracetamol
ATP
Paracetamol
Indications
Toothache
Indication detailsView
Paracetamol is indicated for fever, common cold and influenza, headache, toothache, earache, bodyache, myalgia, neuralgia, dysmenorrhoea, sprains, colic pain, back pain, post-operative pain, postpartum pain, inflammatory pain and post vaccination pain in children. It is also indicated for rheumatic & osteoarthritic pain and stiffness of joints.
Therapeutic classView
Non opioid analgesics
PharmacologyView
Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Paracetamol is a para aminophenol derivative, has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol is one of the most widely used, safest and fast acting analgesic. It is well tolerated and free from various side effects of aspirin.
DosageView
Tablet:
- Adult: 1-2 tablets every 4 to 6 hours up to a maximum of 4 gm (8 tablets) daily.
- Children (6-12 years): ½ to 1 tablet 3 to 4 times daily. For long term treatment it is wise not to exceed the dose beyond 2.6 gm/day.
- Adults & Children over 12 years: Two tablets, swallowed whole, every 6 to 8 hours (maximum of 6 tablets in any 24 hours).The tablet must not be crushed.
- Children under 3 months: 10 mg/kg body weight (reduce to 5 mg/kg if jaundiced) 3 to 4 times daily.
- 3 months to below 1 year: ½ to 1 teaspoonful 3 to 4 times daily.
- 1-5 years: 1 -2 teaspoonful 3 to 4 times daily.
- 6-12 years: 2-A teaspoonful 3 to 4 times daily.
- Adults: 4-8 teaspoonful 3 to 4 times daily.
- Children 3-12 months: 60-120 mg,4 times daily.
- Children 1-5 years: 125-250 mg 4 times daily.
- Children 6-12 years: 250-500 mg 4 times daily.
- Adults & children over 12 years: 0.5-1 gm 4 times daily.
- Children Upto 3 months: 0.5 ml (40 mg)
- 4 to 11 months: 1.0 ml (80 mg)
- 7 to 2 years: 1.5 ml (120 mg). Do not exceed more than 5 dose daily for a maximum of 5 days.
- Adults and children (aged 12 years and over): Take 1 to 2 Tablets every four to six hours as needed. Do not take more than 8 caplets in 24 hours.
- Children (7 to 11 years): Take ½-1 Tablet every four to six hours as needed. Do not take more than 4 caplets in 24 hours. Not recommended in children under 7 years.
Side effectsView
Side effects of paracetamol are usually mild, though haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.
ContraindicationsView
It is contraindicated in known hypersensitivity to Paracetamol.
PrecautionsView
Paracetamol should be given with caution to patients with impaired kidney or liver function. Paracetamol should be given with care to patients taking other drugs that affect the liver.
InteractionsView
Patients who have taken barbiturates, tricyclic antidepressants and alcohol may show diminished ability to metabolise large doses of Paracetamol. Alcohol can increase the hepatotoxicity of Paracetamol overdosage. Chronic ingestion of anticonvulsants or oral steroid contraceptives induce liver enzymes and may prevent attainment of therapeutic Paracetamol levels by increasing first-pass metabolism or clearance.
Pregnancy & lactationView
Pregnancy category B according to USFDA. This drug should be used during pregnancy only if clearly needed
Overdose effectsView
Symptoms of Paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12-48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
ATP
Paracetamol
ATP
Paracetamol
Indications
Toothache
Indication detailsView
Paracetamol is indicated for fever, common cold and influenza, headache, toothache, earache, bodyache, myalgia, neuralgia, dysmenorrhoea, sprains, colic pain, back pain, post-operative pain, postpartum pain, inflammatory pain and post vaccination pain in children. It is also indicated for rheumatic & osteoarthritic pain and stiffness of joints.
Therapeutic classView
Non opioid analgesics
PharmacologyView
Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Paracetamol is a para aminophenol derivative, has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol is one of the most widely used, safest and fast acting analgesic. It is well tolerated and free from various side effects of aspirin.
DosageView
Tablet:
- Adult: 1-2 tablets every 4 to 6 hours up to a maximum of 4 gm (8 tablets) daily.
- Children (6-12 years): ½ to 1 tablet 3 to 4 times daily. For long term treatment it is wise not to exceed the dose beyond 2.6 gm/day.
- Adults & Children over 12 years: Two tablets, swallowed whole, every 6 to 8 hours (maximum of 6 tablets in any 24 hours).The tablet must not be crushed.
- Children under 3 months: 10 mg/kg body weight (reduce to 5 mg/kg if jaundiced) 3 to 4 times daily.
- 3 months to below 1 year: ½ to 1 teaspoonful 3 to 4 times daily.
- 1-5 years: 1 -2 teaspoonful 3 to 4 times daily.
- 6-12 years: 2-A teaspoonful 3 to 4 times daily.
- Adults: 4-8 teaspoonful 3 to 4 times daily.
- Children 3-12 months: 60-120 mg,4 times daily.
- Children 1-5 years: 125-250 mg 4 times daily.
- Children 6-12 years: 250-500 mg 4 times daily.
- Adults & children over 12 years: 0.5-1 gm 4 times daily.
- Children Upto 3 months: 0.5 ml (40 mg)
- 4 to 11 months: 1.0 ml (80 mg)
- 7 to 2 years: 1.5 ml (120 mg). Do not exceed more than 5 dose daily for a maximum of 5 days.
- Adults and children (aged 12 years and over): Take 1 to 2 Tablets every four to six hours as needed. Do not take more than 8 caplets in 24 hours.
- Children (7 to 11 years): Take ½-1 Tablet every four to six hours as needed. Do not take more than 4 caplets in 24 hours. Not recommended in children under 7 years.
Side effectsView
Side effects of paracetamol are usually mild, though haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.
ContraindicationsView
It is contraindicated in known hypersensitivity to Paracetamol.
PrecautionsView
Paracetamol should be given with caution to patients with impaired kidney or liver function. Paracetamol should be given with care to patients taking other drugs that affect the liver.
InteractionsView
Patients who have taken barbiturates, tricyclic antidepressants and alcohol may show diminished ability to metabolise large doses of Paracetamol. Alcohol can increase the hepatotoxicity of Paracetamol overdosage. Chronic ingestion of anticonvulsants or oral steroid contraceptives induce liver enzymes and may prevent attainment of therapeutic Paracetamol levels by increasing first-pass metabolism or clearance.
Pregnancy & lactationView
Pregnancy category B according to USFDA. This drug should be used during pregnancy only if clearly needed
Overdose effectsView
Symptoms of Paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12-48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
ATP Extra
Paracetamol + Caffeine
ATP Extra
Paracetamol + Caffeine
Indications
Toothache
Indication detailsView
The is indicated in the following condition-
- Headache
- Migraine
- Toothache
- Neuralgia
- Feverishness
- Period pain
- Sore throat
- Backache
- Help to reduce the temperature
- Aches and pain of colds and flu
Therapeutic classView
Non opioid analgesics
PharmacologyView
This is a combination of Paracetamol and Caffeine. Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Caffeine is an alkaloid which is a theophylline-like xanthine derivative. By intermolecular association with Paracetamol, Caffeine increases the solubility and transmembrane permeation of Paracetamol. In addition, Caffeine increases the pain threshold and tolerance of pain. Caffeine has also an intrinsic power to raise vessel tone in the brain, which provides another benefit to treat migraine and headache.
DosageView
Adult dose: 1-2 tablets every 4-6 hours. Maximum dose: 8 tablets daily.
Child dose: Not recommended for children below 12 years.
Child dose: Not recommended for children below 12 years.
Side effectsView
Side effects of paracetamol are usually mild, though haematological reactions including thrombocytopenia, leukopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.
ContraindicationsView
Paracetamol is contraindicated in patients with severe renal function impairment and hepatic disease (Viral Hepatitis). Known hypersensitivity to paracetamol or caffeine.
PrecautionsView
Paracetamol & Caffeine should be given cautiously in the following cases: In patients with hepatic or renal failure, in patients taking other hepatotoxic medication. Prolonged use of the drug without consulting a physician should be avoided.
InteractionsView
May reduce serum levels with anticonvulsants (e.g. phenytoin, barbiturates, carbamazepine). May enhance the anticoagulant effect of warfarin and other coumarins with prolonged use. Accelerated absorption with metoclopramide and domperidone. May increase serum levels with probenecid. May increase serum levels of chloramphenicol. May reduce absorption with colestyramine within 1 hr of admin. May cause severe hypothermia with phenothiazine.
Pregnancy & lactationView
Pregnant mothers should consult with doctors before taking Paracetamol & Caffeine. Paracetamol & Caffeine can be taken whilst breast feeding.
Overdose effectsView
Symptoms of Paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 40 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.
StorageView
Store in a cool and dry place, protect from light and moisture.Keep all medicines out of the reach of the children.
ATP XR
Paracetamol
ATP XR
Paracetamol
Indications
Toothache
Indication detailsView
Paracetamol is indicated for fever, common cold and influenza, headache, toothache, earache, bodyache, myalgia, neuralgia, dysmenorrhoea, sprains, colic pain, back pain, post-operative pain, postpartum pain, inflammatory pain and post vaccination pain in children. It is also indicated for rheumatic & osteoarthritic pain and stiffness of joints.
Therapeutic classView
Non opioid analgesics
PharmacologyView
Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Paracetamol is a para aminophenol derivative, has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol is one of the most widely used, safest and fast acting analgesic. It is well tolerated and free from various side effects of aspirin.
DosageView
Tablet:
- Adult: 1-2 tablets every 4 to 6 hours up to a maximum of 4 gm (8 tablets) daily.
- Children (6-12 years): ½ to 1 tablet 3 to 4 times daily. For long term treatment it is wise not to exceed the dose beyond 2.6 gm/day.
- Adults & Children over 12 years: Two tablets, swallowed whole, every 6 to 8 hours (maximum of 6 tablets in any 24 hours).The tablet must not be crushed.
- Children under 3 months: 10 mg/kg body weight (reduce to 5 mg/kg if jaundiced) 3 to 4 times daily.
- 3 months to below 1 year: ½ to 1 teaspoonful 3 to 4 times daily.
- 1-5 years: 1 -2 teaspoonful 3 to 4 times daily.
- 6-12 years: 2-A teaspoonful 3 to 4 times daily.
- Adults: 4-8 teaspoonful 3 to 4 times daily.
- Children 3-12 months: 60-120 mg,4 times daily.
- Children 1-5 years: 125-250 mg 4 times daily.
- Children 6-12 years: 250-500 mg 4 times daily.
- Adults & children over 12 years: 0.5-1 gm 4 times daily.
- Children Upto 3 months: 0.5 ml (40 mg)
- 4 to 11 months: 1.0 ml (80 mg)
- 7 to 2 years: 1.5 ml (120 mg). Do not exceed more than 5 dose daily for a maximum of 5 days.
- Adults and children (aged 12 years and over): Take 1 to 2 Tablets every four to six hours as needed. Do not take more than 8 caplets in 24 hours.
- Children (7 to 11 years): Take ½-1 Tablet every four to six hours as needed. Do not take more than 4 caplets in 24 hours. Not recommended in children under 7 years.
Side effectsView
Side effects of paracetamol are usually mild, though haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.
ContraindicationsView
It is contraindicated in known hypersensitivity to Paracetamol.
PrecautionsView
Paracetamol should be given with caution to patients with impaired kidney or liver function. Paracetamol should be given with care to patients taking other drugs that affect the liver.
InteractionsView
Patients who have taken barbiturates, tricyclic antidepressants and alcohol may show diminished ability to metabolise large doses of Paracetamol. Alcohol can increase the hepatotoxicity of Paracetamol overdosage. Chronic ingestion of anticonvulsants or oral steroid contraceptives induce liver enzymes and may prevent attainment of therapeutic Paracetamol levels by increasing first-pass metabolism or clearance.
Pregnancy & lactationView
Pregnancy category B according to USFDA. This drug should be used during pregnancy only if clearly needed
Overdose effectsView
Symptoms of Paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12-48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.