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Durabolin

Nandrolone Phenylpropionate
IM Injection 25 mg/ml Allopathic Hormone in bone formation by stimulation

Indications

Osteoporosis

Indication detailsView
Nandrolone Phenylpropionate is indicated-
  • As an adjunct to specific therapies and dietary measures in pathologic conditions characterized by a negative nitrogen balance
  • For the palliative treatment of selected cases of disseminated mammary carcinoma in women
  • Osteoporosis.
Therapeutic classView
Anabolic steroid (Androgens), Hormone in bone formation by stimulation
PharmacologyView
Nandrolone Phenylpropionate is an injectable anabolic preparation. The pharmacologically active substance is nandrolone. The phenylpropionate ester gives the preparation a duration of action of about one week after injection. Nandrolone is chemically related to the male hormone. Compared to testosterone, it has an enhanced anabolic and a reduced androgenic activity. This has been demonstrated in animal bioassays and explained by receptor binding studies. The low androgenicity of nandrolone is confirmed in clinical use.

In the human, Nandrolone Phenylpropionate has a nitrogen saving action. This effect on protein metabolism has been established by metabolic studies and is utilized therapeutically in conditions where a protein deficiency exists such as during chronic debilitating diseases and after major surgery and severe trauma. In these conditions, Nandrolone Phenylpropionate serves as a supportive adjunct to specific therapies and dietary measures. In women with disseminated mammary carcinoma, in selected cases Nandrolone Phenylpropionate has been reported to produce objective regressions for many months. Furthermore, Nandrolone Phenylpropionate has been shown to produce relief of bone pain in patients with osteoporosis. The similarly acting nandrolone ester, nandrolone decanoate, has been shown to increase bone mineral content in these patients. Androgenic effects (e.g. virilisation) are relatively uncommon at the recommended dosages. Nandrolone lacks the C17alpha-alkyl group which is associated with the occurrence of liver dysfunction and cholestasis.
DosageView
As an adjunct to specific therapies and dietary measures in pathologic conditions characterized by a negative nitrogen balance: Recommended dose is 25-50 mg every week.

For the palliative treatment of selected cases of disseminated mammary carcinoma in women: Recommended dose is 50 mg every week.

Osteoporosis: Recommended dose is 50 mg every week.

For an optimal therapeutic effect it is necessary to administer adequate amounts of vitamins, minerals and protein in a calorie-rich diet. Nandrolone Phenylpropionate should be administered by deep intramuscular injection.
Side effectsView
High dosages, prolonged treatment and/or too frequent administration may cause:
  • Virilisation which appears in sensitive women as hoarseness, acne hirsutism and increase of libido; in prepubertal boys as an increased frequency of erections and phallic enlargement, and in girls as an increase of pubic hair and clitoral hypertrophy. Hoarseness may be the first symptom of vocal change which may end in a long-lasting, sometimes irreversible deepening of the voice.
  • Amenorrhoea.
  • Inhibition of spermatogenesis.
  • Premature epiphyseal closure.
  • Fluid retention.
ContraindicationsView
Contraindicated in Pregnancy, Known or suspected carcinoma of the prostate or breast in the male.
PrecautionsView
If signs of virilisation develop, discontinuation of the treatment should be considered, Preferably in consultation with the patient.

It is recommended to monitor patients with any of the following conditions:
  • latent or overt cardiac failure, renal dysfunction, hypertension or migraine (or a history of these conditions), since anabolic steroids may occasioally induce fluid retention:
  • incomplete statural growth, since anabolic steroids in high dosages may accelerate epiphyseal closure;
  • skeletal metastases of breast carcinoma. In these patients
  • hypercalcaemia may develop both spontaneously and as a result of anabolic steroid therapy. The later can be indicative of a positive tumour response to the hormonal treatment. Nevertheless, the hypercalcaemia should first be treated appropriately and after restoration of normal calcium levels hormone therapy can be resumed;
  • liver dysfunction.
The use of anabolic steroids to enhance athletic ability may carry severe risks to the user's health and should be discouraged.
InteractionsView
Anabolic steroids may improve glucose tolerance and decrease the need for insulin or other antidiabetic medicines in diabetics.
Pregnancy & lactationView
This medicine is contraindicated during pregnancy because of possible masculinization of the foetus. There are insufficient data on the use of this medicine during breast-feeding to assess potential harm to the infant or a possible influence on milk production.
Overdose effectsView
The acute toxicity of Nandrolone Phenylpropionate in animals is very low. There are no reports of acute overdosage with Nandrolone Phenylpropionate in the human
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Duracain

Bupivacaine Hydrochloride + Dextrose
Intraspinal Injection 0.5%+8% Allopathic Regional anesthesia

Indications

Subarachnoid anesthesia

Indication detailsView
Bupivacaine Hydrochloride & Dextrose is indicated for-
  • Bupivacaine is indicated for lower abdominal surgery (including Caesarean section), urological and lower limb, including hip surgery, lasting 1.5 to 3 hours.
  • Bupivacaine are indicated for intrathecal (subarachnoid, spinal) anesthesia for surgical and obstetrical procedures.
  • Bupivacaine produces motor blockade of the abdominal muscles makes the solution suitable for performance of abdominal surgery lasting 1.5-2 hours. The duration of motor blockade does not exceed the duration of analgesia.
Therapeutic classView
Regional anesthesia
PharmacologyView
Bupivacaineis a long acting anaesthetic agent of the amide type. Bupivacaine & Dextrosehas a rapid onset of action and long duration. The duration of analgesia in the T10-T12 segments is 2-3 hours. Bupivacaine Hydrochloride produces a moderate muscular relaxation of the lower extremities lasting 2-2.5 hours. The motor blockade of the abdominal muscles makes the solution suitable for performance of abdominal surgery lasting 45-60 minutes.
DosageView
The doses recommended below should be regarded as a guide for use in the average adult. Spinal anaesthesia for surgery: 2-4 ml (10-20 mg Bupivacaine hydrochloride). The spread of anaesthesia obtained with Bupivacaine depends on several factors including the volume of the solutions and the position if the patients during and following the injection. When injected in the L3-L4 intervertebral space with the patient in the sitting position, 3 ml of Bupivacaine spreads to the T7- T10 spinal segments. With the patient receiving the injection in the horizontal position and then turned supine, the blockade spine spreads to T4-T7 spinal segments. It should be understood that the level of spinal anaesthetic can be unpredictable in a given patient.
Side effectsView
The adverse reaction profile for Bupivacaine is similar to those for other long acting local anesthetics administered intrathecally. Adverse reactions caused by the drug are difficult to distinguish from the physiological effects of the nerve block (e.g. decrease in blood pressure, bradycardia, temporary urinary retention), events caused directly (e.g. nerve trauma) or indirectly (e.g. epidural abscess) by the needle puncture or events associated to cerebrospinal leakage (eg. postdural puncture headache).
ContraindicationsView
Bupivacaine in Dextrose is contraindicated in patients with a known hypersensitivity to it or to any local anaesthetic agent of the amide type. The following conditions preclude the use of spinal anaesthesia: Severe hemorrhage, severe hypotension or shock and arrhythmias, such as complete heart block, which severely restrict cardiac output,Local infection at the site of proposed lumbar puncture ,Septicemia.
PrecautionsView
Bupivacaine should be given cautiously to the elderly, the debilitated patients and to children, to patients with epilepsy, respiratory impairment, impaired cardiac conduction, bradycardia, severe shock; porphyria; myasthenia gravis. Myocardial depression may be more severe and more resistant to treatment.
InteractionsView
Bupivacaine should be used with care in patients receiving antiarrhythmic drugs with local anaesthetic activity, as their toxic effects may be additive. Phenothiazines and Butyrophenones may reduce or reverse the pressor effect of epinephrine.
Pregnancy & lactationView
It is reasonable to assume that a large number of pregnant women and women of child-bearing age have been given Bupivacaine. No specific disturbances to the reproductive process have so far been reported, e.g. no increased incidence of malformations. It should be noted that the dose should be reduced in patients in the late stages of pregnancy

With recommended doses, Bupivacaine enters breast milk in such small quantities that there is generally no risk of affecting the breast feed child. At maternal serum levels of up to 0.45 µg/ml produced by the epidural use of Bupivacaine for vaginal delivery, Bupivacaine could not be detected in breast milk during the first 24 hours after delivery (detection limit 0.02 µg/ml).
Pediatric usageView
Use in children: Bupivacaine Hydrochloride is not recommended in patients younger than 18 years of age.

Use in elderly and renal impairment: Patients in poor general condition due to ageing or other compromising factors such as partial or complete heart conduction block, advanced liver or renal dysfunction require special attention, although regional anesthesia may be the optimal choice for surgery in these patients.
Overdose effectsView
Acute emergencies from local anaesthetics are generally related to high plasma levels encountered during therapeutic use or to underventilation (and perhaps apnea) secondary to upward extension of spinal anaesthesia. Hypotension is commonly encountered during the conduct of spinal anaesthesia due to relaxation of sympathetic tone, and sometimes, contributory mechanical obstruction of venous return.
StorageView
Store in a cool and dry place. Protect from light.

Duracef

Cefixime Trihydrate
Capsule 200 mg Allopathic Third generation Cephalosporins

Indications

Urethritis

Indication detailsView
Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:
  • Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
  • Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
  • Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
  • Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
  • Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.
DosageView
The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following
  • ½-1 year: 75 mg daily.
  • 1-4 years: 100 mg daily.
  • 5-10 years: 200 mg daily.
  • 11-12 years: 300 mg daily
  • In typhoid fever, dosage should be 10 mg/kg/day for 14 days.
Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.
Side effectsView
The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.
ContraindicationsView
It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.
PrecautionsView
The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.
InteractionsView
Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.
Pregnancy & lactationView
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. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.
Overdose effectsView
Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.
StorageView
Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Duracef

Cefixime Trihydrate
Capsule 400 mg Allopathic Third generation Cephalosporins

Indications

Urethritis

Indication detailsView
Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:
  • Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
  • Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
  • Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
  • Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
  • Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.
DosageView
The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following
  • ½-1 year: 75 mg daily.
  • 1-4 years: 100 mg daily.
  • 5-10 years: 200 mg daily.
  • 11-12 years: 300 mg daily
  • In typhoid fever, dosage should be 10 mg/kg/day for 14 days.
Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.
Side effectsView
The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.
ContraindicationsView
It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.
PrecautionsView
The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.
InteractionsView
Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.
Pregnancy & lactationView
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. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.
Overdose effectsView
Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.
StorageView
Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Duracef

Cefixime Trihydrate
Powder for Suspension 100 mg/5 ml Allopathic Third generation Cephalosporins

Indications

Urethritis

Indication detailsView
Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:
  • Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
  • Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
  • Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
  • Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
  • Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.
DosageView
The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following
  • ½-1 year: 75 mg daily.
  • 1-4 years: 100 mg daily.
  • 5-10 years: 200 mg daily.
  • 11-12 years: 300 mg daily
  • In typhoid fever, dosage should be 10 mg/kg/day for 14 days.
Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.
Side effectsView
The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.
ContraindicationsView
It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.
PrecautionsView
The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.
InteractionsView
Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.
Pregnancy & lactationView
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. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.
Overdose effectsView
Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.
StorageView
Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Duracef

Cefixime Trihydrate
Tablet 200 mg Allopathic Third generation Cephalosporins

Indications

Urethritis

Indication detailsView
Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:
  • Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
  • Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
  • Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
  • Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
  • Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.
DosageView
The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following
  • ½-1 year: 75 mg daily.
  • 1-4 years: 100 mg daily.
  • 5-10 years: 200 mg daily.
  • 11-12 years: 300 mg daily
  • In typhoid fever, dosage should be 10 mg/kg/day for 14 days.
Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.
Side effectsView
The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.
ContraindicationsView
It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.
PrecautionsView
The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.
InteractionsView
Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.
Pregnancy & lactationView
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. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.
Overdose effectsView
Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.
StorageView
Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Duracef

Cefixime Trihydrate
Pediatric Drops 25 mg/ml Allopathic Third generation Cephalosporins

Indications

Urethritis

Indication detailsView
Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:
  • Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
  • Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
  • Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
  • Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
  • Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.
DosageView
The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following
  • ½-1 year: 75 mg daily.
  • 1-4 years: 100 mg daily.
  • 5-10 years: 200 mg daily.
  • 11-12 years: 300 mg daily
  • In typhoid fever, dosage should be 10 mg/kg/day for 14 days.
Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.
Side effectsView
The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.
ContraindicationsView
It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.
PrecautionsView
The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.
InteractionsView
Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.
Pregnancy & lactationView
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. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.
Overdose effectsView
Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.
StorageView
Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Duracef DS

Cefixime Trihydrate
Powder for Suspension 200 mg/5 ml Allopathic Third generation Cephalosporins

Indications

Urethritis

Indication detailsView
Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:
  • Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
  • Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
  • Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
  • Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
  • Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.
DosageView
The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following
  • ½-1 year: 75 mg daily.
  • 1-4 years: 100 mg daily.
  • 5-10 years: 200 mg daily.
  • 11-12 years: 300 mg daily
  • In typhoid fever, dosage should be 10 mg/kg/day for 14 days.
Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.
Side effectsView
The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.
ContraindicationsView
It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.
PrecautionsView
The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.
InteractionsView
Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.
Pregnancy & lactationView
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. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.
Overdose effectsView
Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.
StorageView
Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Duracef-Max

Cefixime Trihydrate
Powder for Suspension 500 mg/5 ml Allopathic Third generation Cephalosporins

Indications

Urethritis

Indication detailsView
Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:
  • Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
  • Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
  • Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
  • Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
  • Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.
DosageView
The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following
  • ½-1 year: 75 mg daily.
  • 1-4 years: 100 mg daily.
  • 5-10 years: 200 mg daily.
  • 11-12 years: 300 mg daily
  • In typhoid fever, dosage should be 10 mg/kg/day for 14 days.
Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.
Side effectsView
The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.
ContraindicationsView
It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.
PrecautionsView
The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.
InteractionsView
Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.
Pregnancy & lactationView
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. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.
Overdose effectsView
Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.
StorageView
Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Duralax

Bisacodyl
Tablet 5 mg Allopathic Stimulant purgatives

Indications

Osmotic purgative

Indication detailsView
Bisacodyl is indicated in the-
  • Treatment of constipation.
  • Preparation for radiographic or endoscopic examination of the colon.
Therapeutic classView
Stimulant purgatives
PharmacologyView
Bisacodyl is a diphenolic compound. Its chemical structure is similar to that of phenolphthalein. It is widely used as a laxative. Bisacodyl acts on the colon to stimulate peristalsis and on the small bowel and colon to increase intraluminal water and electrolytes. When applied to the caecum, Bisacodyl initiates a response in the entire colon.
DosageView
Constipation-
  • Adult: 5-10 mg at night; occasionally necessary to increase to 15-20 mg;
  • Child under 10 years: 5 mg.
Before radiological procedures and surgery-
  • Adult: 10 mg orally at bed-time for 2 days before the examination.
  • Child: half of the adult dose.
Side effectsView
Bisacodyl is free of side effects if taken in the recommended doses. Overuse of bisacodyl may result in diarrhea and malabsorption. Bisacodyl overuse might be expected to deplete potassium.
ContraindicationsView
Ileus, intestinal obstruction, acute surgical abdominal conditions such as acute appendicitis, and acute inflammatory bowel diseases, severe dehydration.
PrecautionsView
Excessive use of bisacodyl may lead to fluid and electrolyte imbalance. Chronic use can cause dependence.
Pregnancy & lactationView
Bisacodyl like other medicines, should not be used during pregnancy especially the first trimester. In breastfeeding women, bisacodyl should be cautiously used.
StorageView
Store in a cool and dry place, protected from light.

Duran

Ranitidine Hydrochloride
Syrup 75 mg/5 ml Allopathic H2 receptor antagonist

Indications

Zollinger-Ellison syndrome

Indication detailsView
Ranitidine is indicated in:
  • Treatment of active duodenal ulcer
  • Benign gastric ulcer
  • Treatment & prevention of ulcer associated with non-steroidal anti-inflammatory agent
  • Post operative stress ulcer.
  • Zollinger-Ellison Syndrome.
  • Gastroesophageal reflux disease (GERD).
  • Gastro-intestinal haemorrhage from stress ulcer in seriously ill patient.
  • Recurrent haemorrhage in patients with bleeding peptic ulcer.
  • Before general anesthesia in patient considered to be at risk of acid aspiration particulary obstetric patients.
Therapeutic classView
H2 receptor antagonist
PharmacologyView
Ranitidine competitively blocks histamine at H2-receptors of the gastric parietal cells which inhibits gastric acid secretion. It does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion or serum gastrin.
DosageView

Ranitidine Tablet & Syrup:

Duodenal and gastric ulcer: The usual dosage is 150 mg twice daily taken in the morning and evening or 300 mg as a single daily dose at night for 4 to 8 weeks.

Reflux oesophagitis: 150 mg twice daily or 300 mg at bed time for up to 8 weeks.

Zollinger Ellison syndrome: 150 mg 3 times daily and increased if necessary up to 6 g daily in divided doses. Dosage should be continued as long as clinically indicated.

Episodic dyspepsia: 150 mg twice daily or 300 mg at bed time for up to 6 weeks.

Maintenance: 150 mg at night for preventing recurrences.

Child (peptic ulcer): 2-4 mg/kg twice daily, maximum 300 mg daily.


Ranitidine IV injection & IV Infusion:

Ranitidine injection may be given either as a slow (over a period of at least two minutes) intravenous injection of 50 mg, after dilution to a volume of 20 ml per 50 mg dose, which may be repeated every six to eight hours; or as an intermittent intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at six to eight hour intervals; or as an intramuscular injection of 50 mg (2 ml) every six to eight hours. In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, parenteral administration may be continued until oral feeding commences.

In the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patient sapriming dose of 50 mg as low as intravenous injection followed by a continuous intravenous infusion of 0.125-0.250 mg/kg/hour may be preferred. In patients considered to be at risk of developing aspiration syndrome Ranitidine injection 50 mg may be given intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anaesthesia.

Children: The recommended oral dose for the treatment of peptic ulcer in children is 2 mg/kg to 4 mg/kg twice daily to a maximum of 300 mg ranitidine per day. Safety and effectiveness of Ranitidine injection have not been established in case of children.
Side effectsView
Ranitidine is well tolerated and side effects are usually uncommon. Altered bowel habit, dizziness, rash, tiredness, reversible confusional states, headache, decreased blood counts, muscle or joint pain have rarely been reported.
ContraindicationsView
Patients hypersensitive to Ranitidine
PrecautionsView
Ranitidine should be given in reduced dosage to patients with impaired renal and hepatic function.
InteractionsView
Delayed absorption and increased peak serum concentration with propantheline bromide. Ranitidine minimally inhibits hepatic metabolism of coumarin anticoagulants, theophylline, diazepam and propanolol. May alter absorption of pH-dependent drugs (e.g. ketoconazole, midazolam, glipizide). May reduce bioavailability with antacids.
Pregnancy & lactationView
Pregnancy: Ranitidine crosses the placenta. But there is no evidence of impaired fertility or harm to the foetus due to Ranitidine. Like other drugs, Ranitidine should only be used during pregnancy if considered essential.

Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.
Pediatric usageView
Use in elderly patients: In clinical trial the ulcer healing rates have been found similar in patients age 65 and over with those in younger patients. Additionally, there was no difference in the incidence of adverse effects.
Overdose effectsView
Ranitidine is very specific in action and accordingly no particular problems are expected following overdosage with the drug. Symptomatic and supportive therapy should be given as appropriate. If required, the drug may be removed from the plasma by haemodiaiysis.
ReconstitutionView
Slow IV inj: Ranitidine 50 mg diluted to a concentration ≤2.5 mg/mL (e.g. total of 20 mL) with NaCl 0.9% inj or dextrose 5% or 10%, lactated Ringer's, Na bicarbonate 5% soln.

Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

Continuous IV infusion:
Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
StorageView
Store in a cool and dry place. protect from light.

Duran

Ranitidine Hydrochloride
IV Infusion 50 mg/100 ml Allopathic H2 receptor antagonist

Indications

Zollinger-Ellison syndrome

Indication detailsView
Ranitidine is indicated in:
  • Treatment of active duodenal ulcer
  • Benign gastric ulcer
  • Treatment & prevention of ulcer associated with non-steroidal anti-inflammatory agent
  • Post operative stress ulcer.
  • Zollinger-Ellison Syndrome.
  • Gastroesophageal reflux disease (GERD).
  • Gastro-intestinal haemorrhage from stress ulcer in seriously ill patient.
  • Recurrent haemorrhage in patients with bleeding peptic ulcer.
  • Before general anesthesia in patient considered to be at risk of acid aspiration particulary obstetric patients.
Therapeutic classView
H2 receptor antagonist
PharmacologyView
Ranitidine competitively blocks histamine at H2-receptors of the gastric parietal cells which inhibits gastric acid secretion. It does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion or serum gastrin.
DosageView

Ranitidine Tablet & Syrup:

Duodenal and gastric ulcer: The usual dosage is 150 mg twice daily taken in the morning and evening or 300 mg as a single daily dose at night for 4 to 8 weeks.

Reflux oesophagitis: 150 mg twice daily or 300 mg at bed time for up to 8 weeks.

Zollinger Ellison syndrome: 150 mg 3 times daily and increased if necessary up to 6 g daily in divided doses. Dosage should be continued as long as clinically indicated.

Episodic dyspepsia: 150 mg twice daily or 300 mg at bed time for up to 6 weeks.

Maintenance: 150 mg at night for preventing recurrences.

Child (peptic ulcer): 2-4 mg/kg twice daily, maximum 300 mg daily.


Ranitidine IV injection & IV Infusion:

Ranitidine injection may be given either as a slow (over a period of at least two minutes) intravenous injection of 50 mg, after dilution to a volume of 20 ml per 50 mg dose, which may be repeated every six to eight hours; or as an intermittent intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at six to eight hour intervals; or as an intramuscular injection of 50 mg (2 ml) every six to eight hours. In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, parenteral administration may be continued until oral feeding commences.

In the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patient sapriming dose of 50 mg as low as intravenous injection followed by a continuous intravenous infusion of 0.125-0.250 mg/kg/hour may be preferred. In patients considered to be at risk of developing aspiration syndrome Ranitidine injection 50 mg may be given intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anaesthesia.

Children: The recommended oral dose for the treatment of peptic ulcer in children is 2 mg/kg to 4 mg/kg twice daily to a maximum of 300 mg ranitidine per day. Safety and effectiveness of Ranitidine injection have not been established in case of children.
Side effectsView
Ranitidine is well tolerated and side effects are usually uncommon. Altered bowel habit, dizziness, rash, tiredness, reversible confusional states, headache, decreased blood counts, muscle or joint pain have rarely been reported.
ContraindicationsView
Patients hypersensitive to Ranitidine
PrecautionsView
Ranitidine should be given in reduced dosage to patients with impaired renal and hepatic function.
InteractionsView
Delayed absorption and increased peak serum concentration with propantheline bromide. Ranitidine minimally inhibits hepatic metabolism of coumarin anticoagulants, theophylline, diazepam and propanolol. May alter absorption of pH-dependent drugs (e.g. ketoconazole, midazolam, glipizide). May reduce bioavailability with antacids.
Pregnancy & lactationView
Pregnancy: Ranitidine crosses the placenta. But there is no evidence of impaired fertility or harm to the foetus due to Ranitidine. Like other drugs, Ranitidine should only be used during pregnancy if considered essential.

Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.
Pediatric usageView
Use in elderly patients: In clinical trial the ulcer healing rates have been found similar in patients age 65 and over with those in younger patients. Additionally, there was no difference in the incidence of adverse effects.
Overdose effectsView
Ranitidine is very specific in action and accordingly no particular problems are expected following overdosage with the drug. Symptomatic and supportive therapy should be given as appropriate. If required, the drug may be removed from the plasma by haemodiaiysis.
ReconstitutionView
Slow IV inj: Ranitidine 50 mg diluted to a concentration ≤2.5 mg/mL (e.g. total of 20 mL) with NaCl 0.9% inj or dextrose 5% or 10%, lactated Ringer's, Na bicarbonate 5% soln.

Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

Continuous IV infusion:
Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
StorageView
Store in a cool and dry place. protect from light.

Duran

Ranitidine Hydrochloride
Tablet 150 mg Allopathic H2 receptor antagonist

Indications

Zollinger-Ellison syndrome

Indication detailsView
Ranitidine is indicated in:
  • Treatment of active duodenal ulcer
  • Benign gastric ulcer
  • Treatment & prevention of ulcer associated with non-steroidal anti-inflammatory agent
  • Post operative stress ulcer.
  • Zollinger-Ellison Syndrome.
  • Gastroesophageal reflux disease (GERD).
  • Gastro-intestinal haemorrhage from stress ulcer in seriously ill patient.
  • Recurrent haemorrhage in patients with bleeding peptic ulcer.
  • Before general anesthesia in patient considered to be at risk of acid aspiration particulary obstetric patients.
Therapeutic classView
H2 receptor antagonist
PharmacologyView
Ranitidine competitively blocks histamine at H2-receptors of the gastric parietal cells which inhibits gastric acid secretion. It does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion or serum gastrin.
DosageView

Ranitidine Tablet & Syrup:

Duodenal and gastric ulcer: The usual dosage is 150 mg twice daily taken in the morning and evening or 300 mg as a single daily dose at night for 4 to 8 weeks.

Reflux oesophagitis: 150 mg twice daily or 300 mg at bed time for up to 8 weeks.

Zollinger Ellison syndrome: 150 mg 3 times daily and increased if necessary up to 6 g daily in divided doses. Dosage should be continued as long as clinically indicated.

Episodic dyspepsia: 150 mg twice daily or 300 mg at bed time for up to 6 weeks.

Maintenance: 150 mg at night for preventing recurrences.

Child (peptic ulcer): 2-4 mg/kg twice daily, maximum 300 mg daily.


Ranitidine IV injection & IV Infusion:

Ranitidine injection may be given either as a slow (over a period of at least two minutes) intravenous injection of 50 mg, after dilution to a volume of 20 ml per 50 mg dose, which may be repeated every six to eight hours; or as an intermittent intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at six to eight hour intervals; or as an intramuscular injection of 50 mg (2 ml) every six to eight hours. In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, parenteral administration may be continued until oral feeding commences.

In the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patient sapriming dose of 50 mg as low as intravenous injection followed by a continuous intravenous infusion of 0.125-0.250 mg/kg/hour may be preferred. In patients considered to be at risk of developing aspiration syndrome Ranitidine injection 50 mg may be given intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anaesthesia.

Children: The recommended oral dose for the treatment of peptic ulcer in children is 2 mg/kg to 4 mg/kg twice daily to a maximum of 300 mg ranitidine per day. Safety and effectiveness of Ranitidine injection have not been established in case of children.
Side effectsView
Ranitidine is well tolerated and side effects are usually uncommon. Altered bowel habit, dizziness, rash, tiredness, reversible confusional states, headache, decreased blood counts, muscle or joint pain have rarely been reported.
ContraindicationsView
Patients hypersensitive to Ranitidine
PrecautionsView
Ranitidine should be given in reduced dosage to patients with impaired renal and hepatic function.
InteractionsView
Delayed absorption and increased peak serum concentration with propantheline bromide. Ranitidine minimally inhibits hepatic metabolism of coumarin anticoagulants, theophylline, diazepam and propanolol. May alter absorption of pH-dependent drugs (e.g. ketoconazole, midazolam, glipizide). May reduce bioavailability with antacids.
Pregnancy & lactationView
Pregnancy: Ranitidine crosses the placenta. But there is no evidence of impaired fertility or harm to the foetus due to Ranitidine. Like other drugs, Ranitidine should only be used during pregnancy if considered essential.

Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.
Pediatric usageView
Use in elderly patients: In clinical trial the ulcer healing rates have been found similar in patients age 65 and over with those in younger patients. Additionally, there was no difference in the incidence of adverse effects.
Overdose effectsView
Ranitidine is very specific in action and accordingly no particular problems are expected following overdosage with the drug. Symptomatic and supportive therapy should be given as appropriate. If required, the drug may be removed from the plasma by haemodiaiysis.
ReconstitutionView
Slow IV inj: Ranitidine 50 mg diluted to a concentration ≤2.5 mg/mL (e.g. total of 20 mL) with NaCl 0.9% inj or dextrose 5% or 10%, lactated Ringer's, Na bicarbonate 5% soln.

Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

Continuous IV infusion:
Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
StorageView
Store in a cool and dry place. protect from light.

Duratab

Habb-e-Nishat
Tablet Herbal Herbal and Nutraceuticals

Indications

Erectile dysfunction

Indication detailsView
This is indicated in Erectile dysfunction, low virility, fluidity of semen and spermatorrhoaea.
Therapeutic classView
Herbal and Nutraceuticals
PharmacologyView
Myristica fragrans (Mace): It is especially effective in helping with male sexual disorders. It increases sexual activity, libido and potency without any conspicuous adverse effects. It also helps to improve circulation of blood in the body and stimulate the brain.

Penaeus spp: It acts as an aphrodisiac and exhilarant. Improves quality blood production.

Argyeria speciosa: This herb is commonly used as an aphrodisiac and is useful in male sex disorders like early ejaculations. It stimulates nervous system.

Myristica fragrans (Nut Meg): It contains volatile oil, proteins, fats, starch and mucilage, acts as aphrodisiac, nervous stimulant and increases blood circulation.

Calx of Tin: It is useful in spermatorrhea, nocturnal emission and premature ejaculation.

Natural Silicate of magnesia & iron: It acts as antidote and exhilarant.

Crocus sativus: It has stimulating action on the nervous system and also has aphrodisiac action.
DosageView
2 tablets with milk one hour before coitus.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Duratocin

Carbetocin
IV Injection 100 mcg/ml Allopathic Drugs acting on the Uterus

Indications

Uterine atony

Indication detailsView
Carbetocin is indicated for the prevention of uterine atony and postpartum haemorrhage (excessive bleeding) following delivery of the infant by elective caesarean section under epidural or spinal anaesthesia.
Therapeutic classView
Drugs acting on the Uterus
PharmacologyView
Carbetocin is a drug used to control postpartum hemorrhage, bleeding after giving birth. It is an analogue of oxytocin, and its action is similar to that of oxytocin; it causes contraction of the uterus. Carbetocin binds to oxytocin receptors present on the smooth musculature of the uterus, resulting in rhythmic contractions of the uterus, increased frequency of existing contractions, and increased uterine tone. The oxytocin receptor content of the uterus is very low in the non-pregnant state, and increases during pregnancy, reaching a peak at the time of delivery.
DosageView
A single intravenous dose of 100 mcg of carbetocin injection is administered by bolus injection, slowly over 1 minute, only when infant delivery has been completed by caesarean section under epidural or spinal anaesthesia. carbetocin is to be used as a single dose only.
Side effectsView
10-40% of patients experienced nausea, vomiting, abdominal pain, itching skin, increased body temperature, trembling and weakness. Infrequent adverse events (1-5% of patients) included back pain, dizziness, metallic taste, anaemia, sweating, chest pain, dyspnoea, chills, tachycardia and anxiety.
ContraindicationsView
Because of its long duration of action relative to oxytocin, uterine contractions produced by carbetocin cannot be stopped by simply discontinuing the medication. Therefore, carbetocin should not be administered prior to delivery of the infant for any reason, including elective or medical induction of labour. Inappropriate use of carbetocin during pregnancy could theoretically mimic the symptoms of oxytocin overdosage, including hyperstimulation of the uterus with strong (hypertonic) or prolonged (tetanic) contractions, tumultuous labour, uterine rupture, cervical and vaginal lacerations, postpartum haemorrhage, utero-placental hypoperfusion and variable deceleration of foetal heart, foetal hypoxia, hypercapnia, or death. Carbetocin should not be used in patients with a history of hypersensitivity to oxytocin or carbetocin. Carbetocin should not be used in patients with cardio vascular disease, especially coronary artery disease, valvular heart disease, cardiomyopathy and heart failure. Carbetocin is not intended for use in children. 
PrecautionsView
  • In patients who may not have an adequate uterine contraction after a single injection of carbetocin, more aggressive treatment with additional doses of oxytocin or ergometrine is warranted.
  • As carbetocin is closely related in structure to oxytocin, hyponatraemia may occur.
  • Carbetocin should be used cautiously in the presence of epilepsy, migraine, asthma or any state in which a rapid addition to extracellular water may produce hazard for an already overburdened system.
  • Patients with eclampsia and pre-eclampsia should be monitored for changes in blood pressure.
  • Carbetocin is not recommended for use in elderly patients.
InteractionsView
No specific drug interactions have been reported with carbetocin.
Pregnancy & lactationView
Use of carbetocin injection is contraindicated during pregnancy. Small amounts of carbetocin has been shown to cross over from plasma into the breast milk of nursing women. The small amount of carbetocin ingested by infant would not be expected to present a significant safety concern.
Overdose effectsView
Overdosage of carbetocin can be expected to produce enhanced pharmacological effects associated with uterine hyperactivity and pain. Treatment consists of symptomatic and supportive management.
StorageView
Store at 2-8°C. Do not freeze. Keep away from light. Once the ampoule has been opened, the product should be used immediately.

Durazol

Albendazole
Oral Suspension 200 mg/5 ml Allopathic Anthelmintic

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:
  • 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 of 1-2 years: Recommended dose is a single dose of 200 mg (5 ml suspension).

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.
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.

Durazol

Albendazole
Chewable Tablet 400 mg Allopathic Anthelmintic

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:
  • 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 of 1-2 years: Recommended dose is a single dose of 200 mg (5 ml suspension).

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.
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.

Duric

Allopurinol
Tablet 100 mg Allopathic Drugs used in Gout

Indications

Uric acid nephropathy

Indication detailsView
Allopurinol is indicated for reducing urate/uric acid formation in conditions where urate/uric acid deposition has already occurred (e.g. gouty arthritis, skin tophi, nephrolithiasis). Allopurinol is indicated for management of 2,8-dihydroxyadenine (2,8-DHA) renal stones related to deficient activity of adenine phospho ribosyltransferase. Allopurinol is indicated for the management of recurrent mixed calcium oxalate renal stones in the presence of hyperuricosuria, when fluid, dietary and similar measures have failed.
Therapeutic classView
Drugs used in Gout
PharmacologyView
Allopurinol is a xanthine oxidase inhibitor which is administered orally. It acts on purine catabolism without disrupting the biosynthesis of purines. It reduces the production of uric acid by inhibiting the biochemical reactions immediately preceding its formation. Allopurinol is a structural analogue of the natural purine base, hypoxanthine. It is an inhibitor of xanthine oxidase, the enzyme responsible for the conversion of hypoxanthine to xanthine and xanthine to uric acid, the end product of purine metabolism. Allopurinol is approximately 90% absorbed from the GI tract. Peak plasma levels generally occur at 1.5 hours to 4.5 hours. It has a plasma half life of about 1 to 2 hours. Approximately 20% of the ingested Allopurinol is excreted in the faeces.
DosageView
Adults: Allopurinol should be introduced at low dosage e.g. 100mg/day to reduce the risk of adverse reactions and increased only if the serum urate response is unsatisfactory. Extra caution should be exercised if renal function is poor. The following dosage schedules are suggested: 100 to 200 mg daily in mild conditions, 300 to 600 mg daily in moderately severe conditions, 700 to 900 mg daily in severe conditions.

Children: Children under 15 years: 10 to 20 mg/kg body weight/day up to a maximum of 400 mg daily. Use in children is rarely indicated, except in malignant conditions (especially leukaemia) and certain enzyme disorders such as Lesch-Nyhan syndrome.

Elderly: In the absence of specific data, the lowest dosage which produces satisfactory urate reduction should be used.

Dosage in renal impairment: In severe renal insufficiency, it may be advisable to use less than 100 mg per day or to use single doses of 100mg at longer intervals than one day.
Side effectsView
Rashes, gastro intestinal disorder’s, rearly malaise, headache, vertigo, drowsiness, visual and test disturbances, hypertension, alopecia, hepatotoxicity, neuropathy, gynaeconastia and blood disorders.
ContraindicationsView
Allopurinol tablet is contra-indicated in patients with known hypersensitive to allopurinol.
PrecautionsView
Allopurinol should be withdrawn immediately when a skin rash or other evidence of sensitivity occurs. Reduced doses should be used in patients with hepatic or renal impairment. Patients under treatment for hypertension or cardiac insufficiency may have some concomitant impairment of renal function and allopurinol should be used with care in this group.
InteractionsView
When 6-mercaptopurine or azathioprine is given concurrently with Allopurinol, only one-quarter of the usual dose of 6- mercaptopurine or azathioprine should be given because inhibition of xanthine oxidase will prolong their activity. Evidence suggests that the plasma half-life of vidarabine is increased in the presence of allopurinol. When the two products are used concomitantly extra vigilance is necessary, to recognise enhanced toxic effects. Theophylline levels should be monitored in patients starting or increasing allopurinol therapy. An increase in frequency of skin rash has been reported among patients receiving ampicillin or amoxicillin concurrently with allopurinol compared to patients who are not receiving both drugs. Reports suggest that the plasma concentration of ciclosporin may be increased during concomitant treatment with allopurinol.
Pregnancy & lactationView
There is inadequate evidence of safety of Allopurinol in human pregnancy. Use in pregnancy only when there is no safer alternative and when the disease itself carries risk for the mother or unborn child. There are no data concerning the effects of allopurinol or its metabolites on the breast-feed baby.
Overdose effectsView
Ingestion of up to 22.5 g allopurinol without adverse effect has been reported. Symptoms and signs including nausea, vomiting, diarrhoea and dizziness have been reported in a patient who ingested 20 gm allopurinol. Adequate hydration to maintain optimum diuresis facilitates excretion of allopurinol and its metabolites. If considered necessary haemodialysis may be used.
StorageView
Store in a cool and dry place, protected from light.

Durogesic

Fentanyl Citrate
Transdermal Patch 25 mcg/hour Allopathic Opioid analgesics

Indications

Relieve pain

Indication detailsView
Fentanyl is indicated for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least 60 mg of oral morphine/day, at least 25 mcg of transdermal Fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Therapeutic classView
Opioid analgesics
PharmacologyView
Fentanyl is an opioid analgesic. Fentanyl interacts predominately with the opioid mu-receptor but also binds to kappa and delta-type opioid receptors. These mu-binding sites are discretely distributed in the human brain, spinal cord, and other tissues. In clinical settings, Fentanyl exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation. Fentanyl may increase the patient's tolerance for pain and decrease the perception of suffering, although the presence of the pain itself may still be recognized. In addition to analgesia, alterations in mood, euphoria and dysphoria, and drowsiness commonly occur. Fentanyl depresses the respiratory centers, depresses the cough reflex, and constricts the pupils.
DosageView
Oral-
  • Starting Dose: The initial dose of Fentanyl should be 100 mcg.
  • Re-dosing patients within a single episode:  Dosing may be repeated once during a single episode of breakthrough pain if pain is not adequately relieved by one Fentanyl dose. Re-dosing may occur 30 minutes after the start of administration of Fentanyl and the same dosage strength should be used.
  • Increasing the dose:  Titration should be initiated using multiples of the 100 mcg Fentanyl tablet. Patients require to titrate above 100 mcg can be instructed to use two 100 mcg tablets (one on each side of the mouth in the buccal cavity). If this dose is not successful in controlling the breakthrough pain episode, the patient may be instructed to place two 100 mcg tablets on each side of the mouth in the buccal cavity (total of four 100 mcg tablets). Titrate above 400 mcg by 200 mcg increments bearing in mind using more than 4 tablets simultaneously has not been studied and it is important to minimize the number of strengths available to patients at any time to prevent confusion and possible overdose. To reduce the risk of overdose during titration, patients should have only one strength of Fentanyl tablet available at any one time.
  • Dosage Adjustment: Generally, the dose of Fentanyl should be increased when patients require more than one dose per breakthrough pain episode for several consecutive episodes.
Injection-
  • Fentanyl injection can be administered intravenously either as a bolus or by infusion & by intramuscular route also. The dose of fentanyl should be individualized according to age, body weight, physical status, underlying pathological condition, use of other drugs and type of surgery and anesthesia.
  • Doses in excess of 200mcg are for use in anesthesia only. As a premedicant, 1-2 ml fentanyl may be given intramuscularly 45 minutes before induction of anesthesia. After IV administration in unpremedicated adult patients, 2ml fentanyl may be expected to provide sufficient analgesia for 10-20 minutes in surgical procedures involving low pain intensity. 10 ml fentanyl injected as a bolus gives analgesia lasting about one hour. The analgesia produced is sufficient for surgery involving moderately painful procedures. Giving a dose of 50mcglkg fentanyl will provide intense analgesia for some four to six hours, for intensely stimulating surgery.
  • Fentanyl may also be given as an infusion. In ventilated patients, a loading dose of fentanyl may be given as a fast infusion of approximately 1 mcg/kg/min for the first 10 minutes followed by an infusion of approximately 0.1 mcg/kg/min. Alternatively the loading dose of fentanyl may be given as a bolus. Infusion rates should be titrated to individual patient response; lower infusion rates may be adequate. Unless it is planned to ventilate post operatively, the infusion should be terminated at about 40 minutes before the end of surgery.
  • Lower infusion rates, e.g. 0.05-0.08 mcg/kg/min. are necessary if spontaneous ventilation .is to be maintained. Higher infusion rates (up to 3 mcg/kg/min) have been used in cardiac surgery. Fentanyl is chemically incompatible with the induction agents thiopentone & methohexitone because of wide differences in pH
  • Use in elderly and debilitated patients: It is wise to reduce the dosage in the elderly and debilitated patients. The effect of the initial dose should be taken into account in determining supplemental doses.
Transdermal-
Intractable chronic pain:
  • Adult: Patches deliver fentanyl in doses that range from: 12-100 mcg/hr. Doses should be individually titrated based on previous use of opioids. Opioid-naive patients: Initially, ≤25 mcg/hr; it is recommended to initially titrate w/ low doses of short-acting opioids before starting fentanyl patches. Patients receiving a strong opioid analgesic: Initial dose should be based on the previous 24-hr opioid requirements. During transfer to fentanyl patches, previous opioid treatment should be phased out gradually. If patient requires doses >100 mcg/hr, >1 patch may be used; consider alternative or additional therapy if doses >300 mcg/hr are required. Replace patch every 72 hr and apply the new patch to a different site; avoid using the same area of skin for a few days.
  • Elderly: Dose reduction may be needed.
AdministrationView
Tablet Administration: Patients should remove the tablet from the blister strip and immediately place the entire tablet in the buccal cavity (above a rear molar, between the upper cheek and gum). Patients should not attempt to split the tablet. The tablet should not be chewed or swallowed, as this will result in lower plasma concentrations than when taken as directed. The tablet should be left between the cheek and gum until it has disintegrated, which usually takes approximately 14-25 minutes. After 30 minutes, if remnants from the tablet remain, they may be swallowed with a glass of water.
Side effectsView
As with other narcotic analgesics, the most common serious adverse reactions reported to occur with Fentanyl are respiratory depression, apnoea, muscular rigidity, myoclonic movements, and bradycardia. Respiratory depression is more likely to occur with intravenous administration if a dose is given too rapidly and it rarely occurs with intramuscular administration.
ContraindicationsView
Fentanyl is contraindicated in the management of acute or postoperative pain. This product must not be used in opioid non-tolerant patients. Fentanyl is contraindicated in patients with known intolerance or hypersensitivity to any of its components or the drug Fentanyl.
PrecautionsView
Opioid analgesics impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g. driving a car or operating machinery). Patients taking Fentanyl should be warned of these dangers and should be counseled accordingly. The use of concomitant CNS active drugs requires special patient care and observation.

Chronic pulmonary disease: Fentanyl should be titrated with caution in patients with chronic obstructive pulmonary disease or pre-existing medical conditions predisposing them to respiratory depression. 

Head injuries and increased intracranial pressure: Opioids may obscure the clinical course of a patient with a head injury and should be used only if clinically warranted.

Cardiac disease: Intravenous Fentanyl may produce bradycardia. Therefore, Fentanyl should be used with caution in patients with bradyarrhythmias.

Hepatic or renal disease: Fentanyl should be used with caution because of the hepatic metabolism and renal excretion of Fentanyl.
InteractionsView
Co-administration of different antifungals, macrolide antibiotics, CNS depressant drugs like ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, and nefazadone may enhance or prolong the effects of Fentanyl. The concomitant use of amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil with Fentanyl may also result in an increase in Fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression.
Pregnancy & lactationView
Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Fentanyl should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Fentanyl is excreted in human milk; therefore Fentanyl should not be used in nursing women because of the possibility of sedation and/or respiratory depression in their infants.
Overdose effectsView
In insufficient overdosage, Fentanyl would produce narcosis, marked skeletal muscle rigidity. Cardio-respiratory depression and cyanosis may also occur. In the presence of hypoventilation or apnoea, oxygen should be administered and respiration should be assisted. A specific narcotic antagonist, such as naloxane, should be available for use as indicated to manage respiratory depression.
StorageView
Store between 20-25°C. Protect from light.

Durogesic

Fentanyl Citrate
Transdermal Patch 50 mcg/hour Allopathic Opioid analgesics

Indications

Relieve pain

Indication detailsView
Fentanyl is indicated for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least 60 mg of oral morphine/day, at least 25 mcg of transdermal Fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Therapeutic classView
Opioid analgesics
PharmacologyView
Fentanyl is an opioid analgesic. Fentanyl interacts predominately with the opioid mu-receptor but also binds to kappa and delta-type opioid receptors. These mu-binding sites are discretely distributed in the human brain, spinal cord, and other tissues. In clinical settings, Fentanyl exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation. Fentanyl may increase the patient's tolerance for pain and decrease the perception of suffering, although the presence of the pain itself may still be recognized. In addition to analgesia, alterations in mood, euphoria and dysphoria, and drowsiness commonly occur. Fentanyl depresses the respiratory centers, depresses the cough reflex, and constricts the pupils.
DosageView
Oral-
  • Starting Dose: The initial dose of Fentanyl should be 100 mcg.
  • Re-dosing patients within a single episode:  Dosing may be repeated once during a single episode of breakthrough pain if pain is not adequately relieved by one Fentanyl dose. Re-dosing may occur 30 minutes after the start of administration of Fentanyl and the same dosage strength should be used.
  • Increasing the dose:  Titration should be initiated using multiples of the 100 mcg Fentanyl tablet. Patients require to titrate above 100 mcg can be instructed to use two 100 mcg tablets (one on each side of the mouth in the buccal cavity). If this dose is not successful in controlling the breakthrough pain episode, the patient may be instructed to place two 100 mcg tablets on each side of the mouth in the buccal cavity (total of four 100 mcg tablets). Titrate above 400 mcg by 200 mcg increments bearing in mind using more than 4 tablets simultaneously has not been studied and it is important to minimize the number of strengths available to patients at any time to prevent confusion and possible overdose. To reduce the risk of overdose during titration, patients should have only one strength of Fentanyl tablet available at any one time.
  • Dosage Adjustment: Generally, the dose of Fentanyl should be increased when patients require more than one dose per breakthrough pain episode for several consecutive episodes.
Injection-
  • Fentanyl injection can be administered intravenously either as a bolus or by infusion & by intramuscular route also. The dose of fentanyl should be individualized according to age, body weight, physical status, underlying pathological condition, use of other drugs and type of surgery and anesthesia.
  • Doses in excess of 200mcg are for use in anesthesia only. As a premedicant, 1-2 ml fentanyl may be given intramuscularly 45 minutes before induction of anesthesia. After IV administration in unpremedicated adult patients, 2ml fentanyl may be expected to provide sufficient analgesia for 10-20 minutes in surgical procedures involving low pain intensity. 10 ml fentanyl injected as a bolus gives analgesia lasting about one hour. The analgesia produced is sufficient for surgery involving moderately painful procedures. Giving a dose of 50mcglkg fentanyl will provide intense analgesia for some four to six hours, for intensely stimulating surgery.
  • Fentanyl may also be given as an infusion. In ventilated patients, a loading dose of fentanyl may be given as a fast infusion of approximately 1 mcg/kg/min for the first 10 minutes followed by an infusion of approximately 0.1 mcg/kg/min. Alternatively the loading dose of fentanyl may be given as a bolus. Infusion rates should be titrated to individual patient response; lower infusion rates may be adequate. Unless it is planned to ventilate post operatively, the infusion should be terminated at about 40 minutes before the end of surgery.
  • Lower infusion rates, e.g. 0.05-0.08 mcg/kg/min. are necessary if spontaneous ventilation .is to be maintained. Higher infusion rates (up to 3 mcg/kg/min) have been used in cardiac surgery. Fentanyl is chemically incompatible with the induction agents thiopentone & methohexitone because of wide differences in pH
  • Use in elderly and debilitated patients: It is wise to reduce the dosage in the elderly and debilitated patients. The effect of the initial dose should be taken into account in determining supplemental doses.
Transdermal-
Intractable chronic pain:
  • Adult: Patches deliver fentanyl in doses that range from: 12-100 mcg/hr. Doses should be individually titrated based on previous use of opioids. Opioid-naive patients: Initially, ≤25 mcg/hr; it is recommended to initially titrate w/ low doses of short-acting opioids before starting fentanyl patches. Patients receiving a strong opioid analgesic: Initial dose should be based on the previous 24-hr opioid requirements. During transfer to fentanyl patches, previous opioid treatment should be phased out gradually. If patient requires doses >100 mcg/hr, >1 patch may be used; consider alternative or additional therapy if doses >300 mcg/hr are required. Replace patch every 72 hr and apply the new patch to a different site; avoid using the same area of skin for a few days.
  • Elderly: Dose reduction may be needed.
AdministrationView
Tablet Administration: Patients should remove the tablet from the blister strip and immediately place the entire tablet in the buccal cavity (above a rear molar, between the upper cheek and gum). Patients should not attempt to split the tablet. The tablet should not be chewed or swallowed, as this will result in lower plasma concentrations than when taken as directed. The tablet should be left between the cheek and gum until it has disintegrated, which usually takes approximately 14-25 minutes. After 30 minutes, if remnants from the tablet remain, they may be swallowed with a glass of water.
Side effectsView
As with other narcotic analgesics, the most common serious adverse reactions reported to occur with Fentanyl are respiratory depression, apnoea, muscular rigidity, myoclonic movements, and bradycardia. Respiratory depression is more likely to occur with intravenous administration if a dose is given too rapidly and it rarely occurs with intramuscular administration.
ContraindicationsView
Fentanyl is contraindicated in the management of acute or postoperative pain. This product must not be used in opioid non-tolerant patients. Fentanyl is contraindicated in patients with known intolerance or hypersensitivity to any of its components or the drug Fentanyl.
PrecautionsView
Opioid analgesics impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g. driving a car or operating machinery). Patients taking Fentanyl should be warned of these dangers and should be counseled accordingly. The use of concomitant CNS active drugs requires special patient care and observation.

Chronic pulmonary disease: Fentanyl should be titrated with caution in patients with chronic obstructive pulmonary disease or pre-existing medical conditions predisposing them to respiratory depression. 

Head injuries and increased intracranial pressure: Opioids may obscure the clinical course of a patient with a head injury and should be used only if clinically warranted.

Cardiac disease: Intravenous Fentanyl may produce bradycardia. Therefore, Fentanyl should be used with caution in patients with bradyarrhythmias.

Hepatic or renal disease: Fentanyl should be used with caution because of the hepatic metabolism and renal excretion of Fentanyl.
InteractionsView
Co-administration of different antifungals, macrolide antibiotics, CNS depressant drugs like ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, and nefazadone may enhance or prolong the effects of Fentanyl. The concomitant use of amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil with Fentanyl may also result in an increase in Fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression.
Pregnancy & lactationView
Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Fentanyl should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Fentanyl is excreted in human milk; therefore Fentanyl should not be used in nursing women because of the possibility of sedation and/or respiratory depression in their infants.
Overdose effectsView
In insufficient overdosage, Fentanyl would produce narcosis, marked skeletal muscle rigidity. Cardio-respiratory depression and cyanosis may also occur. In the presence of hypoventilation or apnoea, oxygen should be administered and respiration should be assisted. A specific narcotic antagonist, such as naloxane, should be available for use as indicated to manage respiratory depression.
StorageView
Store between 20-25°C. Protect from light.