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Dumax
Dapoxetine Hydrochloride
Dumax
Dapoxetine Hydrochloride
Indications
Premature ejaculation
Indication detailsView
Indicated for the treatment of premature ejaculation (PE) in men 18 to 64 years of age, who have all of the following:
- Persistent or recurrent ejaculation with minimal sexual stimulation before, on or shortly after penetration and before the patient wishes.
- Marked personal distress or interpersonal difficulty as a consequence of PE and poor control over ejaculation.
Therapeutic classView
Drugs for Erectile Dysfunction
PharmacologyView
The mechanism of action is thought to be related to inhibition of neuronal reuptake of serotonin and subsequent potentiation of serotonin activity. The central ejaculatory neural circuit comprises spinal and cerebral areas that form a highly interconnected network. The sympathetic, parasympathetic, and somatic spinal centers, under the influence of sensory genital and cerebral stimuli integrated and processed at the spinal cord level, act in synergy to command physiologic events occurring during ejaculation. Experimental evidence indicates that serotonin (5-HT), throughout brain descending pathways, exerts an inhibitory role on ejaculation. To date, three 5-HT receptor subtypes 5-HT(1A), 5-HT(1B), and 5-HT(2C) have been postulated to mediate 5-HT's modulating activity on ejaculation.
DosageView
Adult (18 to 64 years of age): The recommended starting dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. If the effect of 30 mg is insufficient and the side effects are acceptable, the dose may be increased to the maximum recommended dose of 60 mg. The maximum recommended dosing frequency is one dose every 24 hours.
Side effectsView
Dizziness, Headache, Somnolence, Tremor, Blurred vision, Tinnitus, Sinus congestion, Nausea, Diarrhea, Abdominal pain, Dry mouth, Fatigue, Insomnia, Hypertension.
ContraindicationsView
- Patients with known hypersensitivity to Dapoxetine Hydrochloride.
- Patients with significant pathological cardiac conditions such as heart failure (NYHA class II-IV), conduction abnormalities (second or third degree AV block or sick sinus syndrome) not treated with a permanent pacemaker, significant ischemic heart disease of significant valvular disease.
- Concomitant treatment with monoamine oxidase inhibitors (MAOIs), thioridazine. Similarly, MAOIs or thioridazine should not be administered within 7 days after Dapoxetine has been discontinued.
- Concomitant treatment with serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs) or other medicinal/herbal products with serotonergic effects or within 14 days of discontinuing treatment with these medicinal/herbal products.
PrecautionsView
Patient with bleeding disorders, epilepsy, susceptibility to angle-closure glaucoma or raised intraocular pressure. Not intended for use in women. Known CYP2D6 poor metabolisers.
InteractionsView
CNS active medicinal products: The use of Dapoxetine in combination with CNS active medicinal products has not been systematically evaluated in patients with premature ejaculation. Consequently, caution is advised if the concomitant administration of Dapoxetine and such medicinal products is required.
PDE5 inhibitors: Tadalafil did not affect the pharmacokinetics of Dapoxetine. Sildenafil caused slight changes in Dapoxetine pharmacokinetics, which are not expected to be clinically significant. However, Dapoxetine should be prescribed with caution in patients who use PDE5 inhibitors due to possible reduced orthostatic tolerance.
Tamsulosin: Concomitant administration of single or multiple doses of 30 mg or 60 mg Dapoxetine to patients receiving daily doses of Tamsulosin did not result in changes in the pharmacokinetics of Tamsulosin. However, Dapoxetine should be prescribed with caution in patients who use alpha adrenergic receptor antagonists due to possible reduced orthostatic tolerance.
Warfarin: There are no data evaluating the effect of chronic use of Warfarin with Dapoxetine; therefore, caution is advised when Dapoxetine is used in patients taking Warfarin chronically.
Ethanol: Concomitant use of alcohol and Dapoxetine could increase the chance or severity of adverse reactions such as dizziness, drowsiness, slow reflexes, or altered judgment. Combining alcohol with Dapoxetine may increase these alcohol-related effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Dapoxetine.
PDE5 inhibitors: Tadalafil did not affect the pharmacokinetics of Dapoxetine. Sildenafil caused slight changes in Dapoxetine pharmacokinetics, which are not expected to be clinically significant. However, Dapoxetine should be prescribed with caution in patients who use PDE5 inhibitors due to possible reduced orthostatic tolerance.
Tamsulosin: Concomitant administration of single or multiple doses of 30 mg or 60 mg Dapoxetine to patients receiving daily doses of Tamsulosin did not result in changes in the pharmacokinetics of Tamsulosin. However, Dapoxetine should be prescribed with caution in patients who use alpha adrenergic receptor antagonists due to possible reduced orthostatic tolerance.
Warfarin: There are no data evaluating the effect of chronic use of Warfarin with Dapoxetine; therefore, caution is advised when Dapoxetine is used in patients taking Warfarin chronically.
Ethanol: Concomitant use of alcohol and Dapoxetine could increase the chance or severity of adverse reactions such as dizziness, drowsiness, slow reflexes, or altered judgment. Combining alcohol with Dapoxetine may increase these alcohol-related effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Dapoxetine.
Pregnancy & lactationView
Dapoxetine is not indicated for use by women. It is not known either dapoxetine or its metabolites are excreted through human breast milk.
Overdose effectsView
There were no unexpected adverse events in a clinical pharmacology study of Dapoxetine with daily doses up to 240 mg. In general, symptoms of overdose with SSRIs include serotonin-mediated adverse reactions such as somnolence, gastrointestinal disturbances such as nausea and vomiting, tachycardia, tremor, agitation and dizziness. In cases of overdose, standard supportive measures should be adopted as required.
StorageView
Store below 30°C. Protect from light and moisture. Keep out of reach of children
Duo-5
Cefpodoxime Proxetil + Clavulanic Acid
Duo-5
Cefpodoxime Proxetil + Clavulanic Acid
Indications
Urinary tract infection
Indication detailsView
It is indicated in the following infections -
- Acute bacterial exacerbation of chronic bronchitis
- Acute community acquired pneumonia
- Pharyngitis or tonsillitis
- Skin and soft tissue infections
- Urinary tract infections
- Uncomplicated gonorrhea
- Acute maxillary sinusitis
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Cefpodoxime is a third generation semi-synthetic Cephalosporin, exhibits activity against several Gram positive as well as Gram negative microorganisms. This compound is also stable in beta lactamase environment. Cefpodoxime exhibits exceptional activity against methicillin susceptible Staphylococci, Streptococcus pneumoniae, Haemophilus influenzae, Neisseria spp. and Moraxella catarrhalis.
Clavulanic acid is a natural inhibitor of beta lactamase which are produced by Streptomyces clavuligerus. It binds to beta lactamase moieties and inactivates them, thus restricting the Cefpodoxime destruction.
Clavulanic acid is a natural inhibitor of beta lactamase which are produced by Streptomyces clavuligerus. It binds to beta lactamase moieties and inactivates them, thus restricting the Cefpodoxime destruction.
DosageView
For adults (Age 12 years and older):
- Acute bacterial exacerbation of chronic bronchitis: 1 tablet 12 hourly for 10 days
- Acute community acquired pneumonia: 1 tablet 12 hourly for 14 days
- Pharyngitis or tonsillitis: ½ tablet 12 hourly for 5 to 10 days
- Skin and soft tissue infections: 2 tablet 12 hourly for 7 to 14 days
- Urinary tract infections: ½ tablet 12 hourly for 7 days
- Uncomplicated gonorrhea: Single dose
- Acute maxillary sinusitis: 1 tablet 12 hourly for 10 days
Side effectsView
Cefpodoxime is well tolerated. Most common gastrointestinal adverse effects are diarrhea, vomiting and abdominal pain.
ContraindicationsView
Cefpodoxime is contraindicated in patients with known hypersensitivity to Cephalosporins.
PrecautionsView
Cefpodoxime should be administered with caution to patients receiving concurrent treatment with diuretics.
InteractionsView
Concomitant administration of Cefpodoxime at high doses with antacids or H2 blockers reduces peak plasma levels of Cefpodoxime.
Pregnancy & lactationView
US FDA pregnancy category of Cefpodoxime & Clavulanic Acid is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefpodoxime have been shown to be excreted in human milk. So, caution should be exercised when Cefpodoxime is administered to a nursing woman.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Duo-5 LS
Cefpodoxime Proxetil + Clavulanic Acid
Duo-5 LS
Cefpodoxime Proxetil + Clavulanic Acid
Indications
Urinary tract infection
Indication detailsView
It is indicated in the following infections -
- Acute bacterial exacerbation of chronic bronchitis
- Acute community acquired pneumonia
- Pharyngitis or tonsillitis
- Skin and soft tissue infections
- Urinary tract infections
- Uncomplicated gonorrhea
- Acute maxillary sinusitis
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Cefpodoxime is a third generation semi-synthetic Cephalosporin, exhibits activity against several Gram positive as well as Gram negative microorganisms. This compound is also stable in beta lactamase environment. Cefpodoxime exhibits exceptional activity against methicillin susceptible Staphylococci, Streptococcus pneumoniae, Haemophilus influenzae, Neisseria spp. and Moraxella catarrhalis.
Clavulanic acid is a natural inhibitor of beta lactamase which are produced by Streptomyces clavuligerus. It binds to beta lactamase moieties and inactivates them, thus restricting the Cefpodoxime destruction.
Clavulanic acid is a natural inhibitor of beta lactamase which are produced by Streptomyces clavuligerus. It binds to beta lactamase moieties and inactivates them, thus restricting the Cefpodoxime destruction.
DosageView
For adults (Age 12 years and older):
- Acute bacterial exacerbation of chronic bronchitis: 1 tablet 12 hourly for 10 days
- Acute community acquired pneumonia: 1 tablet 12 hourly for 14 days
- Pharyngitis or tonsillitis: ½ tablet 12 hourly for 5 to 10 days
- Skin and soft tissue infections: 2 tablet 12 hourly for 7 to 14 days
- Urinary tract infections: ½ tablet 12 hourly for 7 days
- Uncomplicated gonorrhea: Single dose
- Acute maxillary sinusitis: 1 tablet 12 hourly for 10 days
Side effectsView
Cefpodoxime is well tolerated. Most common gastrointestinal adverse effects are diarrhea, vomiting and abdominal pain.
ContraindicationsView
Cefpodoxime is contraindicated in patients with known hypersensitivity to Cephalosporins.
PrecautionsView
Cefpodoxime should be administered with caution to patients receiving concurrent treatment with diuretics.
InteractionsView
Concomitant administration of Cefpodoxime at high doses with antacids or H2 blockers reduces peak plasma levels of Cefpodoxime.
Pregnancy & lactationView
US FDA pregnancy category of Cefpodoxime & Clavulanic Acid is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefpodoxime have been shown to be excreted in human milk. So, caution should be exercised when Cefpodoxime is administered to a nursing woman.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Duoblock
Amlodipine Besilate + Olmesartan Medoxomil
Duoblock
Amlodipine Besilate + Olmesartan Medoxomil
Indications
Hypertension
Indication detailsView
Indicated for the treatment of hypertension alone or with other antihypertensive agents, to lower blood pressure. This combination drug is indicated as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals. The decision to use a combination as initial therapy should be individualized and shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine has a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
DosageView
Substitute individually titrated components for patients on Amlodipine and Olmesartan Medoxomil. This combination may also be given with increased amounts of Amlodipine, Olmesartan Medoxomil, or both, as needed.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Side effectsView
The most common side effects include peripheral edema, headache, flushing, and dizziness. It can also cause Intestinal problems known a sprue-like enteropathy.
ContraindicationsView
Cannot be co-administered with Aliskiren in patients with diabetes.
PrecautionsView
Amlodipine and Olmesartan Medoxomil combination should be used with caution because there is a risk for-
- Hypotension in volume- or salt depleted patients.
- Vasodilation in patients with severe aortic stenosis.
- Increased frequency, duration or severity of angina or acute Ml in patients with severe obstructive coronary artery disease.
InteractionsView
The antihypertensive effect of angiotensin II receptor antagonists, including Olmesartan Medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors. Blood pressure, renal function and electrolytes should be closely monitored in patients on combination therapy and other agents that affect the RAS.
Pregnancy & lactationView
Pregnancy Category D. Amlodipine and Olmesartan Medoxomil combination should not be used in 2nd and 3rd trimester because it can cause fetal death. When pregnancy is detected this combination should be discontinued as soon as possible. It is not known whether Olmesartan and Amlodipine are excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Pediatric use: The safety and effectiveness have not been established in pediatric patients.
Geriatric use: No overall differences in safety or effectiveness were observed between subjects 65 years of age or older and younger subjects.
Renal impairment: There are no studies in patients with renal impairment.
Hepatic impairment: Initial therapy is not recommended in hepatically impaired patients.
Overdose effectsView
There is no information on over dosage in humans.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Duoblock
Amlodipine Besilate + Olmesartan Medoxomil
Duoblock
Amlodipine Besilate + Olmesartan Medoxomil
Indications
Hypertension
Indication detailsView
Indicated for the treatment of hypertension alone or with other antihypertensive agents, to lower blood pressure. This combination drug is indicated as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals. The decision to use a combination as initial therapy should be individualized and shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine has a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
DosageView
Substitute individually titrated components for patients on Amlodipine and Olmesartan Medoxomil. This combination may also be given with increased amounts of Amlodipine, Olmesartan Medoxomil, or both, as needed.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Side effectsView
The most common side effects include peripheral edema, headache, flushing, and dizziness. It can also cause Intestinal problems known a sprue-like enteropathy.
ContraindicationsView
Cannot be co-administered with Aliskiren in patients with diabetes.
PrecautionsView
Amlodipine and Olmesartan Medoxomil combination should be used with caution because there is a risk for-
- Hypotension in volume- or salt depleted patients.
- Vasodilation in patients with severe aortic stenosis.
- Increased frequency, duration or severity of angina or acute Ml in patients with severe obstructive coronary artery disease.
InteractionsView
The antihypertensive effect of angiotensin II receptor antagonists, including Olmesartan Medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors. Blood pressure, renal function and electrolytes should be closely monitored in patients on combination therapy and other agents that affect the RAS.
Pregnancy & lactationView
Pregnancy Category D. Amlodipine and Olmesartan Medoxomil combination should not be used in 2nd and 3rd trimester because it can cause fetal death. When pregnancy is detected this combination should be discontinued as soon as possible. It is not known whether Olmesartan and Amlodipine are excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Pediatric use: The safety and effectiveness have not been established in pediatric patients.
Geriatric use: No overall differences in safety or effectiveness were observed between subjects 65 years of age or older and younger subjects.
Renal impairment: There are no studies in patients with renal impairment.
Hepatic impairment: Initial therapy is not recommended in hepatically impaired patients.
Overdose effectsView
There is no information on over dosage in humans.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Duocard
Cilnidipine
Duocard
Cilnidipine
Indications
Hypertension
Indication detailsView
Cilnidipine is indicated for the management of hypertension for end-organ protection. It is reported to be useful in elderly patients and in those with diabetes and albuminuria. Cilnidipine has been increasingly used in patients with chronic kidney disease
Hypertension is the term used to describe the presence of high blood pressure. The blood pressure is generated by the force of the blood pumped from the heart against the blood vessels. Thus hypertension is caused when there is too much pressure on the blood vessels and this effect can damage the blood vessel
Hypertension is the term used to describe the presence of high blood pressure. The blood pressure is generated by the force of the blood pumped from the heart against the blood vessels. Thus hypertension is caused when there is too much pressure on the blood vessels and this effect can damage the blood vessel
Therapeutic classView
Calcium-channel blockers
PharmacologyView
Cilnidipine is a dihydropyridine calcium-channel blocker. Cilnidipine binds to the dihydropy-ridine binding sites of the L-type voltage dependent calcium channel and inhibits Ca2+ influx across the cell membranes of vascular smooth muscle cells via this channel, consequently vascular smooth muscle is relaxed, causing vasodilation. Cilnidipine inhibits Ca2+ influx via N-type voltage dependent calcium channels in the sympathetic nerve cell membrane. The inhibition of Ca2+ influx via N-type voltage dependent calcium channel was observed over a similar range of drug concentrations to those inhibiting L-type voltage dependent Ca2+ channels. Consequently, release of norepinephrine from sympathetic nerve terminals would be inhibited. Cilnidipine is considered to suppress the reflex increase in heart rate after blood pressure reduction.
DosageView
Adults: 5-10 mg once daily after breakfast. Maximum dose: 20 mg once daily.
Pediatric use: The safety of Cilnidipine in pediatric patients has not been established.
Elderly use: Since the elderly may be more susceptible to hypotension, therapy should be initiated with the lowest possible dose (5 mg).
Pediatric use: The safety of Cilnidipine in pediatric patients has not been established.
Elderly use: Since the elderly may be more susceptible to hypotension, therapy should be initiated with the lowest possible dose (5 mg).
Side effectsView
The most common side effects of Cilnidipine are: Dizziness; flushing; headache; hypotension; peripheral oedema; palpitations; GI disturbances; increased micturition frequency; lethargy; eye pain; depression.
ContraindicationsView
Cilnidipine is contraindicated in patients with known sensitivity to Cilnidipine or any of the excipients or patients having cardiogenic shock, recent MI or acute unstable angina and severe aortic stenosis.
PrecautionsView
Cilnidipine should be administered with care in the following patients: patients with serious hepatic dysfunction, patients with a history of serious adverse reactions to calcium antagonists. During the discontinuation, the dosage should be gradually decreased under close observation.
InteractionsView
Other anti-hypertensive, antipsychotics that cause hypotension, quinidine, carbamazepine, phenytoin, rifampicin, cimetidine, erythromycin.
Pregnancy & lactationView
Cilnidipine should not be administered in pregnant woman or woman having possibilities of being pregnant. It is also advisable to avoid the administration of Cilnidipine to nursing mothers. However, if the administration is indispensable, the patient should be instructed to discontinue lactation.
StorageView
Store below 30°C, protected from light and moisture. Keep away from reach out of the children.
Duocard
Cilnidipine
Duocard
Cilnidipine
Indications
Hypertension
Indication detailsView
Cilnidipine is indicated for the management of hypertension for end-organ protection. It is reported to be useful in elderly patients and in those with diabetes and albuminuria. Cilnidipine has been increasingly used in patients with chronic kidney disease
Hypertension is the term used to describe the presence of high blood pressure. The blood pressure is generated by the force of the blood pumped from the heart against the blood vessels. Thus hypertension is caused when there is too much pressure on the blood vessels and this effect can damage the blood vessel
Hypertension is the term used to describe the presence of high blood pressure. The blood pressure is generated by the force of the blood pumped from the heart against the blood vessels. Thus hypertension is caused when there is too much pressure on the blood vessels and this effect can damage the blood vessel
Therapeutic classView
Calcium-channel blockers
PharmacologyView
Cilnidipine is a dihydropyridine calcium-channel blocker. Cilnidipine binds to the dihydropy-ridine binding sites of the L-type voltage dependent calcium channel and inhibits Ca2+ influx across the cell membranes of vascular smooth muscle cells via this channel, consequently vascular smooth muscle is relaxed, causing vasodilation. Cilnidipine inhibits Ca2+ influx via N-type voltage dependent calcium channels in the sympathetic nerve cell membrane. The inhibition of Ca2+ influx via N-type voltage dependent calcium channel was observed over a similar range of drug concentrations to those inhibiting L-type voltage dependent Ca2+ channels. Consequently, release of norepinephrine from sympathetic nerve terminals would be inhibited. Cilnidipine is considered to suppress the reflex increase in heart rate after blood pressure reduction.
DosageView
Adults: 5-10 mg once daily after breakfast. Maximum dose: 20 mg once daily.
Pediatric use: The safety of Cilnidipine in pediatric patients has not been established.
Elderly use: Since the elderly may be more susceptible to hypotension, therapy should be initiated with the lowest possible dose (5 mg).
Pediatric use: The safety of Cilnidipine in pediatric patients has not been established.
Elderly use: Since the elderly may be more susceptible to hypotension, therapy should be initiated with the lowest possible dose (5 mg).
Side effectsView
The most common side effects of Cilnidipine are: Dizziness; flushing; headache; hypotension; peripheral oedema; palpitations; GI disturbances; increased micturition frequency; lethargy; eye pain; depression.
ContraindicationsView
Cilnidipine is contraindicated in patients with known sensitivity to Cilnidipine or any of the excipients or patients having cardiogenic shock, recent MI or acute unstable angina and severe aortic stenosis.
PrecautionsView
Cilnidipine should be administered with care in the following patients: patients with serious hepatic dysfunction, patients with a history of serious adverse reactions to calcium antagonists. During the discontinuation, the dosage should be gradually decreased under close observation.
InteractionsView
Other anti-hypertensive, antipsychotics that cause hypotension, quinidine, carbamazepine, phenytoin, rifampicin, cimetidine, erythromycin.
Pregnancy & lactationView
Cilnidipine should not be administered in pregnant woman or woman having possibilities of being pregnant. It is also advisable to avoid the administration of Cilnidipine to nursing mothers. However, if the administration is indispensable, the patient should be instructed to discontinue lactation.
StorageView
Store below 30°C, protected from light and moisture. Keep away from reach out of the children.
Duodart
Tamsulosin Hydrochloride + Dutasteride
Duodart
Tamsulosin Hydrochloride + Dutasteride
Indications
Benign prostatic hyperplasia (BPH)
Indication detailsView
Tamsulosin Hydrochloride & Dutasteride capsule is indicated in-
- Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH).
- Reduction in the risk of acute urinary retention and surgery in patients with moderate to severe symptoms of BPH.
Therapeutic classView
BPH/ Urinary retention/ Urinary incontinence
PharmacologyView
Tamsulosin & Dutasteride is a combination of two drugs with complementary mechanisms of action to improve symptoms in patients with Benign Prostatic Hyperplasia (BPH). Tamsulosin Hydrochloride, an antagonist of alpha1A-adrenoreceptors and Dutasteride, a dual 5 alpha reductase inhibitor (5ARI). Treatment of BPH with alpha1-adrenoreceptor blocking agents and 5ARIs results in an improvement in urine flow rate and a reduction in symptoms of BPH.
Tamsulosin: An alpha1-adrenoreceptor blocking agent that affects the dynamic component of BPH by inhibiting alpha1-adrenoreceptors in the stromal prostatic smooth muscle and bladder neck. Blockade of these adrenoreceptors can cause smooth muscles in the bladder neck and prostate to relax. Specifically, Tamsulosin exhibits selectivity for both alpha 1A and alpha 1D receptors over the alpha1B-adrenoreceptor subtype. These three adrenoreceptor subtypes have a distinct distribution pattern in human tissue. Whereas approximately 70% of the alpha1-receptors in human prostate are of the alpha 1A subtype, the human bladder contains predominantly the alpha 1D subtype while blood vessels express predominantly alpha 1B subtype. It is further believed that blockade of the alpha 1D subtypes in the human obstructed bladder may be responsible for reducing detrusor overactivity and subsequent relief of storage symptoms.
Dutasteride: A synthetic 4-azasteriod compound is a competitive and specific inhibitor of both Type I and Type II 5 alpha-reductase isoenzymes that affects the static component of BPH by inhibiting the conversion of Testosterone to Dihydrotestosterone (DHT) by the enzyme 5 alpha-reductase. 5 alpha-reductase exists as 2 isoforms, Type I and Type II, both of which are present in the prostate. It has been observed that compared to normal tissue, the expression of both isoenzymes are increased in BPH tissue. Dissociation from this complex has been evaluated under in vitro and in vivo conditions and is extremely slow. Dutasteride lowers DHT levels and leads to a reduction in prostatic volume, thereby treating an underlying cause of BPH. Dutasteride does not bind to the human androgen receptor.
Tamsulosin: An alpha1-adrenoreceptor blocking agent that affects the dynamic component of BPH by inhibiting alpha1-adrenoreceptors in the stromal prostatic smooth muscle and bladder neck. Blockade of these adrenoreceptors can cause smooth muscles in the bladder neck and prostate to relax. Specifically, Tamsulosin exhibits selectivity for both alpha 1A and alpha 1D receptors over the alpha1B-adrenoreceptor subtype. These three adrenoreceptor subtypes have a distinct distribution pattern in human tissue. Whereas approximately 70% of the alpha1-receptors in human prostate are of the alpha 1A subtype, the human bladder contains predominantly the alpha 1D subtype while blood vessels express predominantly alpha 1B subtype. It is further believed that blockade of the alpha 1D subtypes in the human obstructed bladder may be responsible for reducing detrusor overactivity and subsequent relief of storage symptoms.
Dutasteride: A synthetic 4-azasteriod compound is a competitive and specific inhibitor of both Type I and Type II 5 alpha-reductase isoenzymes that affects the static component of BPH by inhibiting the conversion of Testosterone to Dihydrotestosterone (DHT) by the enzyme 5 alpha-reductase. 5 alpha-reductase exists as 2 isoforms, Type I and Type II, both of which are present in the prostate. It has been observed that compared to normal tissue, the expression of both isoenzymes are increased in BPH tissue. Dissociation from this complex has been evaluated under in vitro and in vivo conditions and is extremely slow. Dutasteride lowers DHT levels and leads to a reduction in prostatic volume, thereby treating an underlying cause of BPH. Dutasteride does not bind to the human androgen receptor.
DosageView
Adults (including elderly): The recommended dose is one capsule (Tamsulosin Hydrochloride 0.4 mg & Dutasteride 0.5 mg) taken orally approximately 30 minutes after the same meal each day. The capsules should be swallowed whole and not chewed or opened. Where appropriate, this capsule may be used to substitute concomitant Tamsulosin Hydrochloride and Dutasteride in existing dual therapy to simplify treatment. Where clinically appropriate, direct change from Tamsulosin Hydrochloride or Dutasteride monotherapy to this capsule may be considered.
Renal impairment: The effect of renal impairment on Tamsulosin-Dutasteride pharmacokinetics has not been studied. No adjustment in dosage is anticipated for patients with renal impairment.
Hepatic impairment: The effect of hepatic impairment on Tamsulosin-Dutasteride pharmacokinetics has not been studied so caution should be used in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the use of this capsule is contra-indicated.
Renal impairment: The effect of renal impairment on Tamsulosin-Dutasteride pharmacokinetics has not been studied. No adjustment in dosage is anticipated for patients with renal impairment.
Hepatic impairment: The effect of hepatic impairment on Tamsulosin-Dutasteride pharmacokinetics has not been studied so caution should be used in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the use of this capsule is contra-indicated.
Side effectsView
The most common adverse reactions reported in subjects receiving combination therapy were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), ejaculation disorders and dizziness. The percentages of subjects with ejaculation disorders, decreased libido and impotence were higher in the combination therapy group compared with either monotherapy groups.
ContraindicationsView
Tamsulosin-Dutasteride combination is contra-indicated in women and children and adolescents, patients with hypersensitivity to Dutasteride, other 5-alpha reductase inhibitors, Tamsulosin (including Tamsulosin- induced angio-edema), soya, peanut or any of other the excipients, patients with a history of orthostatic hypotension and patients with severe hepatic impairment.
PrecautionsView
Combination therapy should be prescribed after careful benefit risk assessment due to the potential increased risk of adverse events (including cardiac failure) and after consideration of alternative treatment options including monotherapies.
Cardiac failure: In two 4-year clinical studies, the incidence of cardiac failure was higher among subjects taking the combination of Dutasteride and an alpha blocker, primarily Tamsulosin, than it was among subjects not taking the combination. In these two trials, the incidence of cardiac failure was low (1%) and variable between the studies.
Effects on prostate specific antigen (PSA) and prostate cancer detection: Digital rectal examination, as well as other evaluations for prostate cancer or other conditions which can cause the same symptoms as BPH, must be performed on patients prior to initiating therapy with Tamsulosin-Dutasteride combination and periodically thereafter. Serum prostate-specific antigen (PSA) concentration is an important component in the detection of prostate cancer. Tamsulosin-Dutasteride combination causes a decrease in mean serum PSA levels by approximately 50%, after 6 months of treatment. Patients receiving Tamsulosin-Dutasteride combination should have a new PSA baseline established after 6 months of treatment. It is recommended to monitor PSA values regularly thereafter. Any confirmed increase from lowest PSA level while on Tamsulosin-Dutasteride combination may signal the presence of prostate cancer or noncompliance to therapy with Tamsulosin-Dutasteride combination and should be carefully evaluated, even if those values are still within the normal range for men not taking a 5 alpha-reductase inhibitor. In the interpretation of a PSA value for a patient taking Tamsulosin-Dutasteride combination, previous PSA values while on Dutasteride treatment should be sought for comparison. Treatment with Tamsulosin-Dutasteride combination does not interfere with the use of PSA as a tool to assist in the diagnosis of prostate cancer after a new baseline has been established. Total serum PSA levels return to baseline within 6 months of discontinuing treatment. The ratio of free to total PSA remains constant even under the influence of Tamsulosin-Dutasteride combination. If clinicians elect to use percent free PSA as an aid in the detection of prostate cancer in men undergoing Tamsulosin-Dutasteride combination therapy, no adjustment to its value appears necessary.
Prostate cancer and high grade tumours: Results of one clinical study in men at increase risk of prostate cancer revealed a higher incidence of Gleason 8-10 prostate cancers in Dutasteride treated men compared to placebo. The relationship between Dutasteride and high grade prostate cancer is not clear. Men taking Tamsulosin-Dutasteride combination should be regularly evaluated for prostate cancer risk including PSA testing.
Renal impairment: The treatment of severely renally impaired patients (creatinine clearance of less than 10 ml/min) should be approached with caution as these patients have not been studied.
Hypotension: Orthostatic- As with other alpha-blockers, a reduction in blood pressure can occur during treatment with Tamsulosin, as a result of which, rarely, syncope can occur. Patients beginning treatment with Tamsulosin-Dutasteride combination should be cautioned to sit or lie down at the first signs of orthostatic hypotension (dizziness, weakness) until the symptoms have resolved. In order to minimize the potential for developing postural hypotension the patient should be haemodynamically stable on alpha-blocker therapy prior to initiating use of PDE5 inhibitors. Symptomatic: Caution is advised when alpha adrenergic blocking agents including Tamsulosin are coadministered with PDE5 inhibitors (e.g. sildenafil, tadalafil, vardenafil). Alpha adrenergic blockers and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these two drug classes can potentially cause symptomatic hypotension.
Intraoperative Floppy Iris Syndrome: Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients on or previously treated with Tamsulosin. IFIS may lead to increased procedural complications during the operation. The initiation of therapy with Tamsulosin-Dutasteride combination in patients for whom cataract surgery is scheduled is therefore not recommended. Discontinuing Tamsulosin 1-2 weeks prior to cataract surgery is anecdotally considered helpful, but the benefit and duration of stopping therapy prior to cataract surgery has not yet been established. Leaking Capsule: Dutasteride is absorbed through the skin, therefore, women, children and adolescents must avoid contact with leaking capsules. If contact is made with leaking capsules, the contact area should be washed immediately with soap and water.
Hepatic impairment: Tamsulosin-Dutasteride combination has not been studied in patients with liver disease. Caution should be used in the administration of Tamsulosin-Dutasteride combination to patients with mild to moderate hepatic impairment.
Breast neoplasia: Breast cancer has been reported in men taking Dutasteride in clinical trials and during the post-marketing period. Physicians should instruct their patients to promptly report any changes in their breast tissue such as lumps or nipple discharge. Currently it is not clear if there is a causal relationship between the occurrence of male breast cancer and long term use of Dutasteride.
Cardiac failure: In two 4-year clinical studies, the incidence of cardiac failure was higher among subjects taking the combination of Dutasteride and an alpha blocker, primarily Tamsulosin, than it was among subjects not taking the combination. In these two trials, the incidence of cardiac failure was low (1%) and variable between the studies.
Effects on prostate specific antigen (PSA) and prostate cancer detection: Digital rectal examination, as well as other evaluations for prostate cancer or other conditions which can cause the same symptoms as BPH, must be performed on patients prior to initiating therapy with Tamsulosin-Dutasteride combination and periodically thereafter. Serum prostate-specific antigen (PSA) concentration is an important component in the detection of prostate cancer. Tamsulosin-Dutasteride combination causes a decrease in mean serum PSA levels by approximately 50%, after 6 months of treatment. Patients receiving Tamsulosin-Dutasteride combination should have a new PSA baseline established after 6 months of treatment. It is recommended to monitor PSA values regularly thereafter. Any confirmed increase from lowest PSA level while on Tamsulosin-Dutasteride combination may signal the presence of prostate cancer or noncompliance to therapy with Tamsulosin-Dutasteride combination and should be carefully evaluated, even if those values are still within the normal range for men not taking a 5 alpha-reductase inhibitor. In the interpretation of a PSA value for a patient taking Tamsulosin-Dutasteride combination, previous PSA values while on Dutasteride treatment should be sought for comparison. Treatment with Tamsulosin-Dutasteride combination does not interfere with the use of PSA as a tool to assist in the diagnosis of prostate cancer after a new baseline has been established. Total serum PSA levels return to baseline within 6 months of discontinuing treatment. The ratio of free to total PSA remains constant even under the influence of Tamsulosin-Dutasteride combination. If clinicians elect to use percent free PSA as an aid in the detection of prostate cancer in men undergoing Tamsulosin-Dutasteride combination therapy, no adjustment to its value appears necessary.
Prostate cancer and high grade tumours: Results of one clinical study in men at increase risk of prostate cancer revealed a higher incidence of Gleason 8-10 prostate cancers in Dutasteride treated men compared to placebo. The relationship between Dutasteride and high grade prostate cancer is not clear. Men taking Tamsulosin-Dutasteride combination should be regularly evaluated for prostate cancer risk including PSA testing.
Renal impairment: The treatment of severely renally impaired patients (creatinine clearance of less than 10 ml/min) should be approached with caution as these patients have not been studied.
Hypotension: Orthostatic- As with other alpha-blockers, a reduction in blood pressure can occur during treatment with Tamsulosin, as a result of which, rarely, syncope can occur. Patients beginning treatment with Tamsulosin-Dutasteride combination should be cautioned to sit or lie down at the first signs of orthostatic hypotension (dizziness, weakness) until the symptoms have resolved. In order to minimize the potential for developing postural hypotension the patient should be haemodynamically stable on alpha-blocker therapy prior to initiating use of PDE5 inhibitors. Symptomatic: Caution is advised when alpha adrenergic blocking agents including Tamsulosin are coadministered with PDE5 inhibitors (e.g. sildenafil, tadalafil, vardenafil). Alpha adrenergic blockers and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these two drug classes can potentially cause symptomatic hypotension.
Intraoperative Floppy Iris Syndrome: Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients on or previously treated with Tamsulosin. IFIS may lead to increased procedural complications during the operation. The initiation of therapy with Tamsulosin-Dutasteride combination in patients for whom cataract surgery is scheduled is therefore not recommended. Discontinuing Tamsulosin 1-2 weeks prior to cataract surgery is anecdotally considered helpful, but the benefit and duration of stopping therapy prior to cataract surgery has not yet been established. Leaking Capsule: Dutasteride is absorbed through the skin, therefore, women, children and adolescents must avoid contact with leaking capsules. If contact is made with leaking capsules, the contact area should be washed immediately with soap and water.
Hepatic impairment: Tamsulosin-Dutasteride combination has not been studied in patients with liver disease. Caution should be used in the administration of Tamsulosin-Dutasteride combination to patients with mild to moderate hepatic impairment.
Breast neoplasia: Breast cancer has been reported in men taking Dutasteride in clinical trials and during the post-marketing period. Physicians should instruct their patients to promptly report any changes in their breast tissue such as lumps or nipple discharge. Currently it is not clear if there is a causal relationship between the occurrence of male breast cancer and long term use of Dutasteride.
InteractionsView
There have been no drug interaction studies for Dutasteride-Tamsulosin combination.
Effects of other drugs on the pharmacokinetics of Dutasteride: Use together with CYP3A4 and/or P-glycoprotein-inhibitors: Dutasteride is mainly eliminated via metabolism. In vitro studies indicate that this metabolism is catalysed by CYP3A4 and CYP3A5. No formal interaction studies have been performed with potent CYP3A4 inhibitors. However, in a population pharmacokinetic study, Dutasteride serum concentrations were on average 1.6 to 1.8 times greater, respectively, in a small number of patients treated concurrently with verapamil or diltiazem (moderate inhibitors of CYP3A4 and inhibitors of P-glycoprotein) than in other patients. Long-term combination of Dutasteride with drugs that are potent inhibitors of the enzyme CYP3A4 (e.g. ritonavir, indinavir, nefazodone, itraconazole, ketoconazole administered orally) may increase serum concentrations of Dutasteride. Further inhibition of 5-alpha reductase at increased Dutasteride exposure, is not likely. However, a reduction of the Dutasteride dosing frequency can be considered if side effects are noted. It should be noted that in the case of enzyme inhibition, the long half-life may be further prolonged and it can take more than 6 months of concurrent therapy before a new steady state is reached. Administration of 12 g cholestyramine one hour after a 5 mg single dose of Dutasteride did not affect the pharmacokinetics of Dutasteride.
Effects of Dutasteride on the pharmacokinetics of other drugs: In a small study (N=24) of two weeks duration in healthy men, Dutasteride (0.5 mg daily) had no effect on the pharmacokinetics of Tamsulosin or terazosin. There was also no indication of a pharmacodynamic interaction in this study. Dutasteride has no effect on the pharmacokinetics of warfarin or digoxin. This indicates that Dutasteride does not inhibit/induce CYP2C9 or the transporter P-glycoprotein. In vitro interaction studies indicate that Dutasteride does not inhibit the enzymes CYP1A2, CYP2D6, CYP2C9, CYP2C19 or CYP3A4. Tamsulosin: Concomitant administration of Tamsulosin Hydrochloride with drugs which can reduce blood pressure, including anaesthetic agents, PDE5 inhibitors and other alpha-1 adrenergic blockers could lead to enhanced hypotensive effects. Tamsulosin-Dutasteride should not be used in combination with other alpha-1 adrenergic blockers. Concomitant administration of Tamsulosin Hydrochloride (0.4 mg) and cimetidine (400 mg every six hours for six days) resulted in a decrease in the clearance (26%) and an increase in the AUC (44%) of Tamsulosin Hydrochloride. Caution should be used when Tamsulosin-Dutasteride is used in combination with cimetidine. A definitive drug-drug interaction study between Tamsulosin Hydrochloride and warfarin has not been conducted. Results from limited in vitro and in vivo studies are inconclusive. Caution should be exercised with concomitant administration of warfarin and Tamsulosin Hydrochloride. No interactions have been seen when Tamsulosin Hydrochloride was given concomitantly with either atenolol, enalapril, nifedipine or theophylline. Concomitant furosemide brings about a fall in plasma levels of Tamsulosin, but as levels remain within the normal range posology need not be adjusted. In vitro neither diazepam nor propranolol, trichlormethiazide, chlormadinon, amitryptyline, diclofenac, glibenclamide and simvastatin change the free fraction of Tamsulosin in human plasma. Neither does Tamsulosin change the free fractions of diazepam, propranolol, trichlormethiazide, and chlormadinon. No interactions at the level of hepatic metabolism have been seen during in vitro studies with liver microsomal fractions, involving amitriptyline, salbutamol and glibenclamide. Diclofenac however, may increase the elimination rate of Tamsulosin.
Effects of other drugs on the pharmacokinetics of Dutasteride: Use together with CYP3A4 and/or P-glycoprotein-inhibitors: Dutasteride is mainly eliminated via metabolism. In vitro studies indicate that this metabolism is catalysed by CYP3A4 and CYP3A5. No formal interaction studies have been performed with potent CYP3A4 inhibitors. However, in a population pharmacokinetic study, Dutasteride serum concentrations were on average 1.6 to 1.8 times greater, respectively, in a small number of patients treated concurrently with verapamil or diltiazem (moderate inhibitors of CYP3A4 and inhibitors of P-glycoprotein) than in other patients. Long-term combination of Dutasteride with drugs that are potent inhibitors of the enzyme CYP3A4 (e.g. ritonavir, indinavir, nefazodone, itraconazole, ketoconazole administered orally) may increase serum concentrations of Dutasteride. Further inhibition of 5-alpha reductase at increased Dutasteride exposure, is not likely. However, a reduction of the Dutasteride dosing frequency can be considered if side effects are noted. It should be noted that in the case of enzyme inhibition, the long half-life may be further prolonged and it can take more than 6 months of concurrent therapy before a new steady state is reached. Administration of 12 g cholestyramine one hour after a 5 mg single dose of Dutasteride did not affect the pharmacokinetics of Dutasteride.
Effects of Dutasteride on the pharmacokinetics of other drugs: In a small study (N=24) of two weeks duration in healthy men, Dutasteride (0.5 mg daily) had no effect on the pharmacokinetics of Tamsulosin or terazosin. There was also no indication of a pharmacodynamic interaction in this study. Dutasteride has no effect on the pharmacokinetics of warfarin or digoxin. This indicates that Dutasteride does not inhibit/induce CYP2C9 or the transporter P-glycoprotein. In vitro interaction studies indicate that Dutasteride does not inhibit the enzymes CYP1A2, CYP2D6, CYP2C9, CYP2C19 or CYP3A4. Tamsulosin: Concomitant administration of Tamsulosin Hydrochloride with drugs which can reduce blood pressure, including anaesthetic agents, PDE5 inhibitors and other alpha-1 adrenergic blockers could lead to enhanced hypotensive effects. Tamsulosin-Dutasteride should not be used in combination with other alpha-1 adrenergic blockers. Concomitant administration of Tamsulosin Hydrochloride (0.4 mg) and cimetidine (400 mg every six hours for six days) resulted in a decrease in the clearance (26%) and an increase in the AUC (44%) of Tamsulosin Hydrochloride. Caution should be used when Tamsulosin-Dutasteride is used in combination with cimetidine. A definitive drug-drug interaction study between Tamsulosin Hydrochloride and warfarin has not been conducted. Results from limited in vitro and in vivo studies are inconclusive. Caution should be exercised with concomitant administration of warfarin and Tamsulosin Hydrochloride. No interactions have been seen when Tamsulosin Hydrochloride was given concomitantly with either atenolol, enalapril, nifedipine or theophylline. Concomitant furosemide brings about a fall in plasma levels of Tamsulosin, but as levels remain within the normal range posology need not be adjusted. In vitro neither diazepam nor propranolol, trichlormethiazide, chlormadinon, amitryptyline, diclofenac, glibenclamide and simvastatin change the free fraction of Tamsulosin in human plasma. Neither does Tamsulosin change the free fractions of diazepam, propranolol, trichlormethiazide, and chlormadinon. No interactions at the level of hepatic metabolism have been seen during in vitro studies with liver microsomal fractions, involving amitriptyline, salbutamol and glibenclamide. Diclofenac however, may increase the elimination rate of Tamsulosin.
Pregnancy & lactationView
Tamsulosin-Dutasteride combination is contra-indicated for use by women. There have been no studies to investigate the effect of Tamsulosin-Dutasteride combination on pregnancy, lactation and fertility. The following statements reflect the information available from studies with the individual components. Fertility: Dutasteride has been reported to affect semen characteristics (reduction in sperm count, semen volume, and sperm motility) in healthy men. The possibility of reduced male fertility cannot be excluded. Effects of Tamsulosin Hydrochloride on sperm counts or sperm function have not been evaluated.
Pregnancy: As with other 5 alpha reductase inhibitors, Dutasteride inhibits the conversion of testosterone to dihydrotestosterone and may, if administered to a woman carrying a male foetus, inhibit the development of the external genitalia of the foetus. Small amounts of Dutasteride have been recovered from the semen in subjects receiving Dutasteride. It is not known whether a male foetus will be adversely affected if his mother is exposed to the semen of a patient being treated with Dutasteride. As with all 5 alpha reductase inhibitors, when the patient’s partner is or may potentially be pregnant it is recommended that the patient avoids exposure of his partner to semen by use of a condom. Administration of Tamsulosin Hydrochloride to pregnant female rats and rabbits showed no evidence of foetal harm.
Lactation: It is not known whether Tamsulosin or Dutasteride are excreted in human milk.
Pregnancy: As with other 5 alpha reductase inhibitors, Dutasteride inhibits the conversion of testosterone to dihydrotestosterone and may, if administered to a woman carrying a male foetus, inhibit the development of the external genitalia of the foetus. Small amounts of Dutasteride have been recovered from the semen in subjects receiving Dutasteride. It is not known whether a male foetus will be adversely affected if his mother is exposed to the semen of a patient being treated with Dutasteride. As with all 5 alpha reductase inhibitors, when the patient’s partner is or may potentially be pregnant it is recommended that the patient avoids exposure of his partner to semen by use of a condom. Administration of Tamsulosin Hydrochloride to pregnant female rats and rabbits showed no evidence of foetal harm.
Lactation: It is not known whether Tamsulosin or Dutasteride are excreted in human milk.
Overdose effectsView
No data are available with regard to over dosage of Tamsulosin-Dutasteride combination. The following statements reflect the information available on the individual components.
Dutasteride: In volunteer studies, single daily doses of Dutasteride up to 40 mg/day (80 times the therapeutic dose) have been administered for 7 days without significant safety concerns. In clinical studies, doses of 5 mg daily have been administered to subjects for 6 months with no additional adverse effects to those seen at therapeutic doses of 0.5 mg. There is no specific antidote for Dutasteride, therefore, in suspected over dosage symptomatic and supportive treatment should be given as appropriate.
Tamsulosin: Acute overdose with 5 mg Tamsulosin Hydrochloride has been reported. Acute hypotension (systolic blood pressure 70 mm Hg), vomiting and diarrhoea were observed which were treated with fluid replacement and the patient could be discharged the same day. In case of acute hypotension occurring after over dosage cardiovascular support should be given. Blood pressure can be restored and heart rate brought back to normal by lying the patient down. If this does not help then volume expanders, and when necessary, vasopressors could be employed. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help as Tamsulosin is very highly bound to plasma proteins. Measures, such as emesis, can be taken to impede absorption. When large quantities are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative, such as sodium sulphate, can be administered.
Dutasteride: In volunteer studies, single daily doses of Dutasteride up to 40 mg/day (80 times the therapeutic dose) have been administered for 7 days without significant safety concerns. In clinical studies, doses of 5 mg daily have been administered to subjects for 6 months with no additional adverse effects to those seen at therapeutic doses of 0.5 mg. There is no specific antidote for Dutasteride, therefore, in suspected over dosage symptomatic and supportive treatment should be given as appropriate.
Tamsulosin: Acute overdose with 5 mg Tamsulosin Hydrochloride has been reported. Acute hypotension (systolic blood pressure 70 mm Hg), vomiting and diarrhoea were observed which were treated with fluid replacement and the patient could be discharged the same day. In case of acute hypotension occurring after over dosage cardiovascular support should be given. Blood pressure can be restored and heart rate brought back to normal by lying the patient down. If this does not help then volume expanders, and when necessary, vasopressors could be employed. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help as Tamsulosin is very highly bound to plasma proteins. Measures, such as emesis, can be taken to impede absorption. When large quantities are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative, such as sodium sulphate, can be administered.
StorageView
Store in a cool and dry place, protected from light.
Duofilm
Salicylic Acid + Lactic Acid
Duofilm
Salicylic Acid + Lactic Acid
Indications
Warts
Indication detailsView
This is a topical solution indicated in the treatment of warts, corns and calluses.
Information For Patients
Information For Patients
- Warts: A wart is a viral infection of the surface layers of the skin. The incubation period varies from a few weeks to several months. Warts can spread by direct contact with a wart to damaged skin.
- Corns: A corn is a small, hardened area of skin which often looks yellow compared to the surrounding skin. It is typically round or cone-shaped, pointing down into the skin. Corns most often form on the feet and sometimes on the hands and are caused by constant or repeated friction or pressure.
- Calluses: A callus is rough, thickened skin spread over a wide area. Like a corn, it is caused by constant or repeated friction or pressure, but unlike corns, calluses are flat and have normal skin markings.
Therapeutic classView
Combined preparations
PharmacologyView
Salicylic acid is a widely used and effective keratolytic, it produces desquamation and destruction of the epithelium by solubilising the intercellular cement of the Stratum Corneum. Lactic acid affects the keratinisation process, reducing hyperkeratosis and is also caustic, leading to the destruction of hyperkeratotic tissue. Collodion is derived from cellulose in a base containing ethanol and ether. It allows easy and accurate application of the product and dries to leave a film which hydrates the tissue and facilitates penetration of the active ingredients.
DosageView
Unscrew bottle cap and with the help of brush applicator, apply to the affected areas. ‘Before starting to use this topical solution, unscrew the fitted cap, discard it. Carefully remove the plug away from your body to avoid splashing into eyes/ face and discard it, replace with the brush applicator cap provided in
the sealed polybag given in the carton. This topical solution should be applied to the affected areas once daily, according to the following instructions:
the sealed polybag given in the carton. This topical solution should be applied to the affected areas once daily, according to the following instructions:
- Soak affected site in hot water for five minutes.
- Rub surface carefully with pumice stone or emeryboard to remove any hard skin. Dry with your own towel.
- Apply this topical solution using the brush applicator supplied, taking care to avoid contact with normal skin.
- Allow to dry thoroughly and cover with plaster if lesion is large or on the foot to help penetration of active ingredients.
- Continue treatment once daily until the lesion is completely cleared and the ridge lines of the skin have been restored or when the corn can be removed.
- The usual treatment period is 6 to 12 weeks.
Side effectsView
Stinging, burning, or irritation of the skin,Itching, prolonged use over a large skin area may cause salicylate toxicity, ringing sound in the ears (tinnitus), Diarrhoea, Vomiting.
ContraindicationsView
Not for prolonged use in high concentrations and on large areas of the body. Impaired peripheral circulation or diabetes. Avoid broken skin, mouth, eyes, mucous membranes and anogenital region.
PrecautionsView
This preparation is formulated for the controlled corrosion of keratin and thus care should be taken to apply the product to the affected area only. Do not use on the face or anogenital regions or if you are diabetic or have impaired circulation. Do not use on moles, birthmarks or unusual skin growths. Do not treat warts over large areas at one time, or use on infants and very young children unless on medical advice. For External Use Only
InteractionsView
There are no known drug interactions and none well documented.
Pregnancy & lactationView
Pregnancy Category- Not Classified. FDA has not yet classified the drug into a specified pregnancy category.
Overdose effectsView
Excessive topical use may result in burning, particularly of normal skin. Following excessive topical use, apply emollients as required. Following ingestion, administer copious quantities of water and antacids as required. Ingestion may cause nausea, vomiting and abdominal pain.
StorageView
In view of its high inflammability, it is recommended that Salicylic Acid & Lactic Acid be stored in a cool place not exceeding 25°C. Keep away from naked flame. Keep out of reach of children. Since this topical solution is volatile, close the bottle tightly after each use.
Duofix
Naproxen Sodium + Esomeprazole Magnesium
Duofix
Naproxen Sodium + Esomeprazole Magnesium
Indications
Systemic lupus erythematosus (SLE)
Indication detailsView
Naproxen & Esomeprazole is indicated for the relief of signs & symptoms of-
- Osteoarthritis
- Rheumatoid arthritis
- Ankylosing spondylitis &
- To decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
This consists of an immediate release Esomeprazole Magnesium layer & an enteric-coated Naproxen core. As a result, Esomeprazole is released first into the stomach, prior to the dissolution of Naproxen in the small intestine.
Naproxen is a NSAID with analgesic & antipyretic properties. The mechanism of action of Naproxen is to inhibit the prostaglandin synthesis. Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/k+ -ATPase in the gastric parietal cell by acting specifically on the proton pump, Esomeprazole blocks the final step in acid production, thus reducing gastric acidity.
Naproxen is a NSAID with analgesic & antipyretic properties. The mechanism of action of Naproxen is to inhibit the prostaglandin synthesis. Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/k+ -ATPase in the gastric parietal cell by acting specifically on the proton pump, Esomeprazole blocks the final step in acid production, thus reducing gastric acidity.
DosageView
Carefully consider the potential benefits & risks of this tablet & other treatment options before deciding to use this tablet. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. If a dose of Esomeprazole lower than a total daily dose of 40 mg is more appropriate, a different treatment should be considered.
Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis-
Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis-
- Adults: One tablet twice daily of either: 375 mg naproxen/20 mg of esomeprazole; or 500 mg naproxen/20 mg of esomeprazole
- Weight greater than 50 kg: 375 mg naproxen/20 mg of esomeprazole; or 500 mg naproxen/20 mg of esomeprazole
- Weight 38 kg to less than 50 kg: One tablet twice daily of 375 mg naproxen/20 mg of esomeprazole.
AdministrationView
Do not split, chew, crush or dissolve the tablet. This tablet is to be taken at least 30 minutes before meals.
Side effectsView
In general, this preparation is well tolerated. The most common adverse reactions in clinical trials (>5%): erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, nausea etc.
ContraindicationsView
- Known hypersensitivity to any component of this tablet or substituted benzimidazoles.
- History of asthmay urticaria or other allergic-type reactions after taking aspirin or other NSAIDs.
- Use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery.
PrecautionsView
Patients with known CV disease/risk factors may be at greater risk. This tablet should be used with caution in patients with fluid retention or heart failure.
InteractionsView
With medicine:
- Concomitant use of NSAIDs may reduce the antihypertensive effect of ACE inhibitors, diuretics & beta-blockers
- Concomitant use of this tablet and warfarin may result in an increased risk of a bleeding complication.
- Esomeprazole inhibits gastric acid secretion & may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg. Ketoconazole, iron salts and digoxin).
Pregnancy & lactationView
Pregnancy category C. In late pregnancy, it should be avoided because it may cause premature closure of the ductus arteriosus. This tablet should not be used in nursing mothers due to the Naproxen component.
Pediatric usageView
Elderly patients: Studies indicate that although the total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Use caution when high doses are required & some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly use the lowest effective dose.
Patients with Moderate to Severe Renal impairment: Naproxen-containing products are not recommended for use in patients with moderate to severe or severe renal impairment (creatinine clearance <30 ml/min).
Hepatic insufficiency: Monitor patients with mild to moderate hepatic impairment closely & consider a possible dose reduction based on the Naproxen component of this tablet. This is not recommended in patients with severe hepatic impairment because Esomeprazole dosage should not exceed 20 mg daily in these patients.
Patients with Moderate to Severe Renal impairment: Naproxen-containing products are not recommended for use in patients with moderate to severe or severe renal impairment (creatinine clearance <30 ml/min).
Hepatic insufficiency: Monitor patients with mild to moderate hepatic impairment closely & consider a possible dose reduction based on the Naproxen component of this tablet. This is not recommended in patients with severe hepatic impairment because Esomeprazole dosage should not exceed 20 mg daily in these patients.
Overdose effectsView
There is no clinical data on overdosage with this tablet.
Overdose of Naproxen: Significant naproxen overdosage may be characterized by lethargy, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alteration in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, vomiting etc.
Overdose of Esomeprazole: The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor and intermittent clonic convulsions etc.
Overdose of Naproxen: Significant naproxen overdosage may be characterized by lethargy, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alteration in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, vomiting etc.
Overdose of Esomeprazole: The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor and intermittent clonic convulsions etc.
StorageView
Store at temperature of below 30°C, protect from light & moisture. Keep out of reach of children.
Duofix
Naproxen Sodium + Esomeprazole Magnesium
Duofix
Naproxen Sodium + Esomeprazole Magnesium
Indications
Systemic lupus erythematosus (SLE)
Indication detailsView
Naproxen & Esomeprazole is indicated for the relief of signs & symptoms of-
- Osteoarthritis
- Rheumatoid arthritis
- Ankylosing spondylitis &
- To decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
This consists of an immediate release Esomeprazole Magnesium layer & an enteric-coated Naproxen core. As a result, Esomeprazole is released first into the stomach, prior to the dissolution of Naproxen in the small intestine.
Naproxen is a NSAID with analgesic & antipyretic properties. The mechanism of action of Naproxen is to inhibit the prostaglandin synthesis. Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/k+ -ATPase in the gastric parietal cell by acting specifically on the proton pump, Esomeprazole blocks the final step in acid production, thus reducing gastric acidity.
Naproxen is a NSAID with analgesic & antipyretic properties. The mechanism of action of Naproxen is to inhibit the prostaglandin synthesis. Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/k+ -ATPase in the gastric parietal cell by acting specifically on the proton pump, Esomeprazole blocks the final step in acid production, thus reducing gastric acidity.
DosageView
Carefully consider the potential benefits & risks of this tablet & other treatment options before deciding to use this tablet. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. If a dose of Esomeprazole lower than a total daily dose of 40 mg is more appropriate, a different treatment should be considered.
Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis-
Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis-
- Adults: One tablet twice daily of either: 375 mg naproxen/20 mg of esomeprazole; or 500 mg naproxen/20 mg of esomeprazole
- Weight greater than 50 kg: 375 mg naproxen/20 mg of esomeprazole; or 500 mg naproxen/20 mg of esomeprazole
- Weight 38 kg to less than 50 kg: One tablet twice daily of 375 mg naproxen/20 mg of esomeprazole.
AdministrationView
Do not split, chew, crush or dissolve the tablet. This tablet is to be taken at least 30 minutes before meals.
Side effectsView
In general, this preparation is well tolerated. The most common adverse reactions in clinical trials (>5%): erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, nausea etc.
ContraindicationsView
- Known hypersensitivity to any component of this tablet or substituted benzimidazoles.
- History of asthmay urticaria or other allergic-type reactions after taking aspirin or other NSAIDs.
- Use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery.
PrecautionsView
Patients with known CV disease/risk factors may be at greater risk. This tablet should be used with caution in patients with fluid retention or heart failure.
InteractionsView
With medicine:
- Concomitant use of NSAIDs may reduce the antihypertensive effect of ACE inhibitors, diuretics & beta-blockers
- Concomitant use of this tablet and warfarin may result in an increased risk of a bleeding complication.
- Esomeprazole inhibits gastric acid secretion & may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg. Ketoconazole, iron salts and digoxin).
Pregnancy & lactationView
Pregnancy category C. In late pregnancy, it should be avoided because it may cause premature closure of the ductus arteriosus. This tablet should not be used in nursing mothers due to the Naproxen component.
Pediatric usageView
Elderly patients: Studies indicate that although the total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Use caution when high doses are required & some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly use the lowest effective dose.
Patients with Moderate to Severe Renal impairment: Naproxen-containing products are not recommended for use in patients with moderate to severe or severe renal impairment (creatinine clearance <30 ml/min).
Hepatic insufficiency: Monitor patients with mild to moderate hepatic impairment closely & consider a possible dose reduction based on the Naproxen component of this tablet. This is not recommended in patients with severe hepatic impairment because Esomeprazole dosage should not exceed 20 mg daily in these patients.
Patients with Moderate to Severe Renal impairment: Naproxen-containing products are not recommended for use in patients with moderate to severe or severe renal impairment (creatinine clearance <30 ml/min).
Hepatic insufficiency: Monitor patients with mild to moderate hepatic impairment closely & consider a possible dose reduction based on the Naproxen component of this tablet. This is not recommended in patients with severe hepatic impairment because Esomeprazole dosage should not exceed 20 mg daily in these patients.
Overdose effectsView
There is no clinical data on overdosage with this tablet.
Overdose of Naproxen: Significant naproxen overdosage may be characterized by lethargy, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alteration in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, vomiting etc.
Overdose of Esomeprazole: The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor and intermittent clonic convulsions etc.
Overdose of Naproxen: Significant naproxen overdosage may be characterized by lethargy, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alteration in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, vomiting etc.
Overdose of Esomeprazole: The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor and intermittent clonic convulsions etc.
StorageView
Store at temperature of below 30°C, protect from light & moisture. Keep out of reach of children.
Duoflam
Salicylic Acid + Lactic Acid
Duoflam
Salicylic Acid + Lactic Acid
Indications
Warts
Indication detailsView
This is a topical solution indicated in the treatment of warts, corns and calluses.
Information For Patients
Information For Patients
- Warts: A wart is a viral infection of the surface layers of the skin. The incubation period varies from a few weeks to several months. Warts can spread by direct contact with a wart to damaged skin.
- Corns: A corn is a small, hardened area of skin which often looks yellow compared to the surrounding skin. It is typically round or cone-shaped, pointing down into the skin. Corns most often form on the feet and sometimes on the hands and are caused by constant or repeated friction or pressure.
- Calluses: A callus is rough, thickened skin spread over a wide area. Like a corn, it is caused by constant or repeated friction or pressure, but unlike corns, calluses are flat and have normal skin markings.
Therapeutic classView
Combined preparations
PharmacologyView
Salicylic acid is a widely used and effective keratolytic, it produces desquamation and destruction of the epithelium by solubilising the intercellular cement of the Stratum Corneum. Lactic acid affects the keratinisation process, reducing hyperkeratosis and is also caustic, leading to the destruction of hyperkeratotic tissue. Collodion is derived from cellulose in a base containing ethanol and ether. It allows easy and accurate application of the product and dries to leave a film which hydrates the tissue and facilitates penetration of the active ingredients.
DosageView
Unscrew bottle cap and with the help of brush applicator, apply to the affected areas. ‘Before starting to use this topical solution, unscrew the fitted cap, discard it. Carefully remove the plug away from your body to avoid splashing into eyes/ face and discard it, replace with the brush applicator cap provided in
the sealed polybag given in the carton. This topical solution should be applied to the affected areas once daily, according to the following instructions:
the sealed polybag given in the carton. This topical solution should be applied to the affected areas once daily, according to the following instructions:
- Soak affected site in hot water for five minutes.
- Rub surface carefully with pumice stone or emeryboard to remove any hard skin. Dry with your own towel.
- Apply this topical solution using the brush applicator supplied, taking care to avoid contact with normal skin.
- Allow to dry thoroughly and cover with plaster if lesion is large or on the foot to help penetration of active ingredients.
- Continue treatment once daily until the lesion is completely cleared and the ridge lines of the skin have been restored or when the corn can be removed.
- The usual treatment period is 6 to 12 weeks.
Side effectsView
Stinging, burning, or irritation of the skin,Itching, prolonged use over a large skin area may cause salicylate toxicity, ringing sound in the ears (tinnitus), Diarrhoea, Vomiting.
ContraindicationsView
Not for prolonged use in high concentrations and on large areas of the body. Impaired peripheral circulation or diabetes. Avoid broken skin, mouth, eyes, mucous membranes and anogenital region.
PrecautionsView
This preparation is formulated for the controlled corrosion of keratin and thus care should be taken to apply the product to the affected area only. Do not use on the face or anogenital regions or if you are diabetic or have impaired circulation. Do not use on moles, birthmarks or unusual skin growths. Do not treat warts over large areas at one time, or use on infants and very young children unless on medical advice. For External Use Only
InteractionsView
There are no known drug interactions and none well documented.
Pregnancy & lactationView
Pregnancy Category- Not Classified. FDA has not yet classified the drug into a specified pregnancy category.
Overdose effectsView
Excessive topical use may result in burning, particularly of normal skin. Following excessive topical use, apply emollients as required. Following ingestion, administer copious quantities of water and antacids as required. Ingestion may cause nausea, vomiting and abdominal pain.
StorageView
In view of its high inflammability, it is recommended that Salicylic Acid & Lactic Acid be stored in a cool place not exceeding 25°C. Keep away from naked flame. Keep out of reach of children. Since this topical solution is volatile, close the bottle tightly after each use.
Duolax
Magnesium Hydroxide + Liquid Paraffin
Duolax
Magnesium Hydroxide + Liquid Paraffin
Indications
Constipation
Indication detailsView
This preparation is indicated in-
- Constipation
- Hyperacidity with constipation
- Anorectal disorder
- Post-operative constipation
- Constipation associated with chronic cholecystitis
- Hernia
Therapeutic classView
Antacid with laxative action
PharmacologyView
This preparation has a dual-relief formulation containing a gentle laxative ingredient and a lubricant which eases the discomfort associated with straining and bowel movement. It is recommended for the temporary relief of constipation
DosageView
The recommended oral dose are as follows-
Adults: 15-30ml before breakfast or at bedtime.
Children:
Adults: 15-30ml before breakfast or at bedtime.
Children:
- Over 7 years: 7.5 ml-15 ml at bedtime.
- 3-7 years: 5-10 ml at bedtime.
Side effectsView
Rectal irritation, potassium loss (thirst, weakness, nausea and diarrhea).
ContraindicationsView
Acute Gl conditions like abdominal pain.
PrecautionsView
Renal and hepatic impairment. Maintain adequate fluid intake.
InteractionsView
Cimetidine, Diuretics, Famotidine and Ranitidine may cause irritation of stomach or bowel.
Pregnancy & lactationView
Can be given to pregnant and lactating mother.
Overdose effectsView
There are no reported cases of overdosage.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Duomeal
Aluminium Hydroxide + Magnesium Hydroxide
Duomeal
Aluminium Hydroxide + Magnesium Hydroxide
Indications
Upper Gl bloating
Indication detailsView
Aluminium Hydroxide and Magnesium Hydroxide is indicated for Hyperacidity, peptic ulcer, gastritis, heartburn, sour stomach & dyspepsia.
Therapeutic classView
Antacids
PharmacologyView
This drug is well-balanced combination of essential non-systemic antacids which excel in efficacy and palatability. These are dependable antacid preparations without acid rebound, constipating or cathertic effects. Both the preparations provide symptomatic relief of hyperacidity associated with heartburn, acid ingestion or sour stomach.
Aluminium hydroxide gel, a slow acting antacid and an adsorbent with prolonged effect, has high neutralizing power. Magnesium Hydroxide possesses a slow but sustained acid neutralizing property. Antacids of both tablet and suspension possess adsorbent property. They form a protecting coating over the ulcer surface facilitating its healing; thus protecting the sensitive mucosa of stomach and duodenum from further irritation.
Aluminium hydroxide gel, a slow acting antacid and an adsorbent with prolonged effect, has high neutralizing power. Magnesium Hydroxide possesses a slow but sustained acid neutralizing property. Antacids of both tablet and suspension possess adsorbent property. They form a protecting coating over the ulcer surface facilitating its healing; thus protecting the sensitive mucosa of stomach and duodenum from further irritation.
DosageView
Tablet: Two tablets 1-3 hours after meal and at bed time or as directed by the physician.
Suspension: 2 tea spoonful 1-3 hours after meal and at bed time or as directed by the physician.
Suspension: 2 tea spoonful 1-3 hours after meal and at bed time or as directed by the physician.
Side effectsView
Long term use of any antacid results in alkaluria, which may predispose to nephrolithiasis by forming precipitation of calcium phosphate.
ContraindicationsView
This is contraindicated in hypophosphataemia. It is also contraindicated in alkalosis and hypermagnesaemia where abdominal distention may be due to partial or complete intestinal obstruction.
PrecautionsView
Antacids reduce the absorption of tetracycline when given concomitantly. These should not be used concomitantly
InteractionsView
This drug inhibits the absorption of following drugs: Azithromycin, cefpodoxime, ciprofloxacin, isoniazid, rifampicin, norfloxacin, ofloxacin, pivampicillin, tetracyclines, Gabapentin and phenytoin, Itraconazole, ketoconazole, Chloroquine, hydroxychloroquine and Phenothiazines.
Pregnancy & lactationView
It is advised to avoid antacid preparations in the first trimester of pregnancy.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Duomeal
Aluminium Hydroxide + Magnesium Hydroxide
Duomeal
Aluminium Hydroxide + Magnesium Hydroxide
Indications
Upper Gl bloating
Indication detailsView
Aluminium Hydroxide and Magnesium Hydroxide is indicated for Hyperacidity, peptic ulcer, gastritis, heartburn, sour stomach & dyspepsia.
Therapeutic classView
Antacids
PharmacologyView
This drug is well-balanced combination of essential non-systemic antacids which excel in efficacy and palatability. These are dependable antacid preparations without acid rebound, constipating or cathertic effects. Both the preparations provide symptomatic relief of hyperacidity associated with heartburn, acid ingestion or sour stomach.
Aluminium hydroxide gel, a slow acting antacid and an adsorbent with prolonged effect, has high neutralizing power. Magnesium Hydroxide possesses a slow but sustained acid neutralizing property. Antacids of both tablet and suspension possess adsorbent property. They form a protecting coating over the ulcer surface facilitating its healing; thus protecting the sensitive mucosa of stomach and duodenum from further irritation.
Aluminium hydroxide gel, a slow acting antacid and an adsorbent with prolonged effect, has high neutralizing power. Magnesium Hydroxide possesses a slow but sustained acid neutralizing property. Antacids of both tablet and suspension possess adsorbent property. They form a protecting coating over the ulcer surface facilitating its healing; thus protecting the sensitive mucosa of stomach and duodenum from further irritation.
DosageView
Tablet: Two tablets 1-3 hours after meal and at bed time or as directed by the physician.
Suspension: 2 tea spoonful 1-3 hours after meal and at bed time or as directed by the physician.
Suspension: 2 tea spoonful 1-3 hours after meal and at bed time or as directed by the physician.
Side effectsView
Long term use of any antacid results in alkaluria, which may predispose to nephrolithiasis by forming precipitation of calcium phosphate.
ContraindicationsView
This is contraindicated in hypophosphataemia. It is also contraindicated in alkalosis and hypermagnesaemia where abdominal distention may be due to partial or complete intestinal obstruction.
PrecautionsView
Antacids reduce the absorption of tetracycline when given concomitantly. These should not be used concomitantly
InteractionsView
This drug inhibits the absorption of following drugs: Azithromycin, cefpodoxime, ciprofloxacin, isoniazid, rifampicin, norfloxacin, ofloxacin, pivampicillin, tetracyclines, Gabapentin and phenytoin, Itraconazole, ketoconazole, Chloroquine, hydroxychloroquine and Phenothiazines.
Pregnancy & lactationView
It is advised to avoid antacid preparations in the first trimester of pregnancy.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Duopres
Amlodipine Besilate + Olmesartan Medoxomil
Duopres
Amlodipine Besilate + Olmesartan Medoxomil
Indications
Hypertension
Indication detailsView
Indicated for the treatment of hypertension alone or with other antihypertensive agents, to lower blood pressure. This combination drug is indicated as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals. The decision to use a combination as initial therapy should be individualized and shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine has a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
DosageView
Substitute individually titrated components for patients on Amlodipine and Olmesartan Medoxomil. This combination may also be given with increased amounts of Amlodipine, Olmesartan Medoxomil, or both, as needed.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Side effectsView
The most common side effects include peripheral edema, headache, flushing, and dizziness. It can also cause Intestinal problems known a sprue-like enteropathy.
ContraindicationsView
Cannot be co-administered with Aliskiren in patients with diabetes.
PrecautionsView
Amlodipine and Olmesartan Medoxomil combination should be used with caution because there is a risk for-
- Hypotension in volume- or salt depleted patients.
- Vasodilation in patients with severe aortic stenosis.
- Increased frequency, duration or severity of angina or acute Ml in patients with severe obstructive coronary artery disease.
InteractionsView
The antihypertensive effect of angiotensin II receptor antagonists, including Olmesartan Medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors. Blood pressure, renal function and electrolytes should be closely monitored in patients on combination therapy and other agents that affect the RAS.
Pregnancy & lactationView
Pregnancy Category D. Amlodipine and Olmesartan Medoxomil combination should not be used in 2nd and 3rd trimester because it can cause fetal death. When pregnancy is detected this combination should be discontinued as soon as possible. It is not known whether Olmesartan and Amlodipine are excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Pediatric use: The safety and effectiveness have not been established in pediatric patients.
Geriatric use: No overall differences in safety or effectiveness were observed between subjects 65 years of age or older and younger subjects.
Renal impairment: There are no studies in patients with renal impairment.
Hepatic impairment: Initial therapy is not recommended in hepatically impaired patients.
Overdose effectsView
There is no information on over dosage in humans.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Duopres
Amlodipine Besilate + Olmesartan Medoxomil
Duopres
Amlodipine Besilate + Olmesartan Medoxomil
Indications
Hypertension
Indication detailsView
Indicated for the treatment of hypertension alone or with other antihypertensive agents, to lower blood pressure. This combination drug is indicated as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals. The decision to use a combination as initial therapy should be individualized and shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine has a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
DosageView
Substitute individually titrated components for patients on Amlodipine and Olmesartan Medoxomil. This combination may also be given with increased amounts of Amlodipine, Olmesartan Medoxomil, or both, as needed.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Side effectsView
The most common side effects include peripheral edema, headache, flushing, and dizziness. It can also cause Intestinal problems known a sprue-like enteropathy.
ContraindicationsView
Cannot be co-administered with Aliskiren in patients with diabetes.
PrecautionsView
Amlodipine and Olmesartan Medoxomil combination should be used with caution because there is a risk for-
- Hypotension in volume- or salt depleted patients.
- Vasodilation in patients with severe aortic stenosis.
- Increased frequency, duration or severity of angina or acute Ml in patients with severe obstructive coronary artery disease.
InteractionsView
The antihypertensive effect of angiotensin II receptor antagonists, including Olmesartan Medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors. Blood pressure, renal function and electrolytes should be closely monitored in patients on combination therapy and other agents that affect the RAS.
Pregnancy & lactationView
Pregnancy Category D. Amlodipine and Olmesartan Medoxomil combination should not be used in 2nd and 3rd trimester because it can cause fetal death. When pregnancy is detected this combination should be discontinued as soon as possible. It is not known whether Olmesartan and Amlodipine are excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Pediatric use: The safety and effectiveness have not been established in pediatric patients.
Geriatric use: No overall differences in safety or effectiveness were observed between subjects 65 years of age or older and younger subjects.
Renal impairment: There are no studies in patients with renal impairment.
Hepatic impairment: Initial therapy is not recommended in hepatically impaired patients.
Overdose effectsView
There is no information on over dosage in humans.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Duovas
Amlodipine Besilate + Olmesartan Medoxomil
Duovas
Amlodipine Besilate + Olmesartan Medoxomil
Indications
Hypertension
Indication detailsView
Indicated for the treatment of hypertension alone or with other antihypertensive agents, to lower blood pressure. This combination drug is indicated as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals. The decision to use a combination as initial therapy should be individualized and shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine has a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
DosageView
Substitute individually titrated components for patients on Amlodipine and Olmesartan Medoxomil. This combination may also be given with increased amounts of Amlodipine, Olmesartan Medoxomil, or both, as needed.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Side effectsView
The most common side effects include peripheral edema, headache, flushing, and dizziness. It can also cause Intestinal problems known a sprue-like enteropathy.
ContraindicationsView
Cannot be co-administered with Aliskiren in patients with diabetes.
PrecautionsView
Amlodipine and Olmesartan Medoxomil combination should be used with caution because there is a risk for-
- Hypotension in volume- or salt depleted patients.
- Vasodilation in patients with severe aortic stenosis.
- Increased frequency, duration or severity of angina or acute Ml in patients with severe obstructive coronary artery disease.
InteractionsView
The antihypertensive effect of angiotensin II receptor antagonists, including Olmesartan Medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors. Blood pressure, renal function and electrolytes should be closely monitored in patients on combination therapy and other agents that affect the RAS.
Pregnancy & lactationView
Pregnancy Category D. Amlodipine and Olmesartan Medoxomil combination should not be used in 2nd and 3rd trimester because it can cause fetal death. When pregnancy is detected this combination should be discontinued as soon as possible. It is not known whether Olmesartan and Amlodipine are excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Pediatric use: The safety and effectiveness have not been established in pediatric patients.
Geriatric use: No overall differences in safety or effectiveness were observed between subjects 65 years of age or older and younger subjects.
Renal impairment: There are no studies in patients with renal impairment.
Hepatic impairment: Initial therapy is not recommended in hepatically impaired patients.
Overdose effectsView
There is no information on over dosage in humans.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Duovas
Amlodipine Besilate + Olmesartan Medoxomil
Duovas
Amlodipine Besilate + Olmesartan Medoxomil
Indications
Hypertension
Indication detailsView
Indicated for the treatment of hypertension alone or with other antihypertensive agents, to lower blood pressure. This combination drug is indicated as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals. The decision to use a combination as initial therapy should be individualized and shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine has a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
DosageView
Substitute individually titrated components for patients on Amlodipine and Olmesartan Medoxomil. This combination may also be given with increased amounts of Amlodipine, Olmesartan Medoxomil, or both, as needed.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Side effectsView
The most common side effects include peripheral edema, headache, flushing, and dizziness. It can also cause Intestinal problems known a sprue-like enteropathy.
ContraindicationsView
Cannot be co-administered with Aliskiren in patients with diabetes.
PrecautionsView
Amlodipine and Olmesartan Medoxomil combination should be used with caution because there is a risk for-
- Hypotension in volume- or salt depleted patients.
- Vasodilation in patients with severe aortic stenosis.
- Increased frequency, duration or severity of angina or acute Ml in patients with severe obstructive coronary artery disease.
InteractionsView
The antihypertensive effect of angiotensin II receptor antagonists, including Olmesartan Medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors. Blood pressure, renal function and electrolytes should be closely monitored in patients on combination therapy and other agents that affect the RAS.
Pregnancy & lactationView
Pregnancy Category D. Amlodipine and Olmesartan Medoxomil combination should not be used in 2nd and 3rd trimester because it can cause fetal death. When pregnancy is detected this combination should be discontinued as soon as possible. It is not known whether Olmesartan and Amlodipine are excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Pediatric use: The safety and effectiveness have not been established in pediatric patients.
Geriatric use: No overall differences in safety or effectiveness were observed between subjects 65 years of age or older and younger subjects.
Renal impairment: There are no studies in patients with renal impairment.
Hepatic impairment: Initial therapy is not recommended in hepatically impaired patients.
Overdose effectsView
There is no information on over dosage in humans.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Duphaston
Dydrogesterone
Duphaston
Dydrogesterone
Indications
Uterine bleeding
Indication detailsView
Progesterone deficiencies:
- Treatment of threatened miscarriage
- Treatment of habitual miscarriage
- Treatment of dysmenorrhoea
- Treatment of endometriosis
- Treatment of secondary amenorrhoea
- Treatment of irregular cycles
- Treatment of dysfunctional uterine bleeding
- Treatment of infertility due to luteal insufficiency
- Luteal support as part of an Assisted Reproductive Technology (ART)
Therapeutic classView
Female Sex hormones
PharmacologyView
Dydrogesterone is an orally-active progestogen which produces a complete secretory endometrium in an oestrogen-primed uterus thereby providing protection against the increased risk for endometrium hyperplasia and carcinogenesis induced by oestrogens. It is indicated in all cases of endogenous progesterone deficiency. Dydrogesterone has no oestrogenic, no androgenic, no thermogenic, no anabolic and no corticoid activity.
DosageView
Always take Presentation 10 mg tablet exactly as your doctor has prescribed.
Presentationerone deficiencies:
Presentationerone deficiencies:
- Threatened miscarriage: 40 mg (four tablets) at once, then 10 mg (one tablet) every eight hours until symptoms remit.
- Habitual miscarriage: 10 mg (one tablet) twice daily until the twentieth week of pregnancy.
- Dysmenorrhoea: 10 mg (one tablet) twice daily from day 5 to day 25 of the menstrual cycle.
- Endometriosis: 10 mg (one tablet) two or three times daily from day 5 to day 25 of the cycle or continuously.
- Dysfunctional bleeding (to arrest bleeding): 10 mg (one tablet) twice daily for five to seven days. Presentation should be given with oestrogen.
- Dysfunctional bleeding (to prevent bleeding): 10 mg (one tablet) twice daily from day 11 to day 25 of the cycle. Presentation should be given with oestrogen.
- Amenorrhoea: An oestrogen once daily from day 1 to day 25 of the cycle, together with 10 mg Presentation twice daily from day 11 to day 25 of the cycle.
- Irregular cycles: 10 mg (one tablet) twice daily from day 11 to day 25 of the cycle.
- Infertility due to luteal insufficiency: 10 mg (one tablet) daily from day 14 to day 25 of the cycle. The treatment should be continued for at least 6 consecutive cycles. It is advisable to continue this treatment during the first month of any pregnancy using the doses stated with respect to habitual miscarriage.
- Luteal support as part of an Assisted Reproductive Technology (ART) treatment: 10 mg three times daily (three tablets daily) starting at the day of oocyte retrieval and continuing for 10 weeks if pregnancy is confirmed.
Side effectsView
The most commonly reported adverse drug reactions of patients treated with Dydrogesterone in clinical trials of indications without oestrogen treatment are migraines/headache, nausea, menstrual disorders and breast pain/tenderness.
ContraindicationsView
Known hypersensitivity to the active substance or to any of the excipients. Known or suspected progestogen dependent neoplasms (e.g. meningioma).
PrecautionsView
Before initiating dydrogesterone treatment for abnormal bleeding the etiology for the bleeding should be clarified. Breakthrough bleeding and spotting may occur during the first months of treatment. If breakthrough bleeding or spotting appears after some time on therapy, or continues after treatment has been discontinued, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy. If one of the following disorders occurs during use for the first time or gets worse, stopping the treatment should be considered.
- Severe headache, migraine or symptoms that may indicate cerebral ischemia.
- Marked increase in blood pressure.
- Occurrence of venous thromboembolism (VTE)
Pregnancy & lactationView
It is estimated that more than 10 million pregnancies have been exposed to Dydrogesterone. So far there were no indications of a harmful effect of Dydrogesterone use during pregnancy. No data exist on excretion of Dydrogesterone in mother's milk. Experience with other progestogens indicates that progestogens and the metabolites pass to mother's milk in small quantities. Whether there is a risk to the child is not known. Therefore Dydrogesterone should not be used during the lactation period.
Overdose effectsView
Dydrogesterone was well tolerated after oral dosing (maximum daily dose is 360 mg). No reports of ill effects from overdose have been recorded. If a large overdose is discovered within two or three hours and treatment seems desirable, gastric lavage is recommended. There are no specific antidotes and treatment should be symptomatic.
StorageView
Store at below 30°C in a dry place protected from light. Keep out of reach of children.