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Cough suppressant

Butamirate Citrate acts directly on the brain's cough center to suppress cough. Butamirate Citrate is safe and non-sedating which is neither chemically nor pharmacologically related to opium alkaloids. Butamirate Citrate is rapidly and completely absorbed after oral administration. Maximum concentration is reached within 9 hours with the sustained-release tablet. This is extremely protein-bound and plasma elimination half-life is about 13 hours. The active metabolites of Butamirate Citrate have also antitussive action.

Use in adult:

• Butamirate Citrate 50 mg tablet: 2-3 tablets daily.
• Butamirate Citrate syrup: 15 ml 4 times daily.

Use in children & adolescents:
Butamirate Citrate 50 mg tablet:

• Adolescent over 12 years old: 1-2 tablets daily.

Butamirate Citrate syrup:

• Children (3-6 yrs): 5 ml 3 times daily.
• Children (6-12 yrs): 10 ml 3 times daily.
• Adolescent: 15 ml 3 times daily.

Butamirate Citrate pediatric drops:

• Children ( 2 months- 1 yrs): 0.50 ml 4 times daily.
• Children (1-3 yrs): 0.75 ml 4 times daily.

Tolerance of Butamirate Citrate is good.Adverse reactions such as rash,nausea,diarrhoea and vertigo have been observed in a few rare cases,resolving after dose reduction or treatment withdrawal.

Hypersensitivity to the active ingredient.

Butamirate Citrate suppresses the cough reflex and therefore the concomitant use with expectorants should be avoided, since it may lead to mucus retention in the airways, which increases the risk of bronchospasm and respiratory infections. If the cough persists for more than 7 days (more than 3 days in children younger than12 years of age) doctor must be consulted.

Concomitant use with expectorants should be avoided.

Butamirate Citrate should not be used during the first trimester of pregnancy. During the remainder of pregnancy, it can be used if indicated by a physician but with caution. As a general rule, for safety reasons, in the absence of data on elimination of the active substance in breast milk, the benefits of Butamirate Citrate administration during breast feeding should be carefully weighed against the risks.

Accidental overdose with Butamirate Citrate can cause the following symptoms: drowsiness, nausea, vomiting, diarrhoea, loss of balance and hypotension. Standard emergency procedures should be followed: activated charcoal, saline laxatives and standard cardio-respiratory resuscitation.

Keep away from light and moisture, store below 30°C. Keep all the medicines out of the reach of children.

Cough suppressant

Butamirate Citrate acts directly on the brain's cough center to suppress cough. Butamirate Citrate is safe and non-sedating which is neither chemically nor pharmacologically related to opium alkaloids. Butamirate Citrate is rapidly and completely absorbed after oral administration. Maximum concentration is reached within 9 hours with the sustained-release tablet. This is extremely protein-bound and plasma elimination half-life is about 13 hours. The active metabolites of Butamirate Citrate have also antitussive action.

Use in adult:

• Butamirate Citrate 50 mg tablet: 2-3 tablets daily.
• Butamirate Citrate syrup: 15 ml 4 times daily.

Use in children & adolescents:
Butamirate Citrate 50 mg tablet:

• Adolescent over 12 years old: 1-2 tablets daily.

Butamirate Citrate syrup:

• Children (3-6 yrs): 5 ml 3 times daily.
• Children (6-12 yrs): 10 ml 3 times daily.
• Adolescent: 15 ml 3 times daily.

Butamirate Citrate pediatric drops:

• Children ( 2 months- 1 yrs): 0.50 ml 4 times daily.
• Children (1-3 yrs): 0.75 ml 4 times daily.

Tolerance of Butamirate Citrate is good.Adverse reactions such as rash,nausea,diarrhoea and vertigo have been observed in a few rare cases,resolving after dose reduction or treatment withdrawal.

Hypersensitivity to the active ingredient.

Butamirate Citrate suppresses the cough reflex and therefore the concomitant use with expectorants should be avoided, since it may lead to mucus retention in the airways, which increases the risk of bronchospasm and respiratory infections. If the cough persists for more than 7 days (more than 3 days in children younger than12 years of age) doctor must be consulted.

Concomitant use with expectorants should be avoided.

Butamirate Citrate should not be used during the first trimester of pregnancy. During the remainder of pregnancy, it can be used if indicated by a physician but with caution. As a general rule, for safety reasons, in the absence of data on elimination of the active substance in breast milk, the benefits of Butamirate Citrate administration during breast feeding should be carefully weighed against the risks.

Accidental overdose with Butamirate Citrate can cause the following symptoms: drowsiness, nausea, vomiting, diarrhoea, loss of balance and hypotension. Standard emergency procedures should be followed: activated charcoal, saline laxatives and standard cardio-respiratory resuscitation.

Keep away from light and moisture, store below 30°C. Keep all the medicines out of the reach of children.

Cough suppressant

Butamirate Citrate acts directly on the brain's cough center to suppress cough. Butamirate Citrate is safe and non-sedating which is neither chemically nor pharmacologically related to opium alkaloids. Butamirate Citrate is rapidly and completely absorbed after oral administration. Maximum concentration is reached within 9 hours with the sustained-release tablet. This is extremely protein-bound and plasma elimination half-life is about 13 hours. The active metabolites of Butamirate Citrate have also antitussive action.

Use in adult:

• Butamirate Citrate 50 mg tablet: 2-3 tablets daily.
• Butamirate Citrate syrup: 15 ml 4 times daily.

Use in children & adolescents:
Butamirate Citrate 50 mg tablet:

• Adolescent over 12 years old: 1-2 tablets daily.

Butamirate Citrate syrup:

• Children (3-6 yrs): 5 ml 3 times daily.
• Children (6-12 yrs): 10 ml 3 times daily.
• Adolescent: 15 ml 3 times daily.

Butamirate Citrate pediatric drops:

• Children ( 2 months- 1 yrs): 0.50 ml 4 times daily.
• Children (1-3 yrs): 0.75 ml 4 times daily.

Tolerance of Butamirate Citrate is good.Adverse reactions such as rash,nausea,diarrhoea and vertigo have been observed in a few rare cases,resolving after dose reduction or treatment withdrawal.

Hypersensitivity to the active ingredient.

Butamirate Citrate suppresses the cough reflex and therefore the concomitant use with expectorants should be avoided, since it may lead to mucus retention in the airways, which increases the risk of bronchospasm and respiratory infections. If the cough persists for more than 7 days (more than 3 days in children younger than12 years of age) doctor must be consulted.

Concomitant use with expectorants should be avoided.

Butamirate Citrate should not be used during the first trimester of pregnancy. During the remainder of pregnancy, it can be used if indicated by a physician but with caution. As a general rule, for safety reasons, in the absence of data on elimination of the active substance in breast milk, the benefits of Butamirate Citrate administration during breast feeding should be carefully weighed against the risks.

Accidental overdose with Butamirate Citrate can cause the following symptoms: drowsiness, nausea, vomiting, diarrhoea, loss of balance and hypotension. Standard emergency procedures should be followed: activated charcoal, saline laxatives and standard cardio-respiratory resuscitation.

Keep away from light and moisture, store below 30°C. Keep all the medicines out of the reach of children.

Cough suppressant

Butamirate Citrate acts directly on the brain's cough center to suppress cough. Butamirate Citrate is safe and non-sedating which is neither chemically nor pharmacologically related to opium alkaloids. Butamirate Citrate is rapidly and completely absorbed after oral administration. Maximum concentration is reached within 9 hours with the sustained-release tablet. This is extremely protein-bound and plasma elimination half-life is about 13 hours. The active metabolites of Butamirate Citrate have also antitussive action.

Use in adult:

• Butamirate Citrate 50 mg tablet: 2-3 tablets daily.
• Butamirate Citrate syrup: 15 ml 4 times daily.

Use in children & adolescents:
Butamirate Citrate 50 mg tablet:

• Adolescent over 12 years old: 1-2 tablets daily.

Butamirate Citrate syrup:

• Children (3-6 yrs): 5 ml 3 times daily.
• Children (6-12 yrs): 10 ml 3 times daily.
• Adolescent: 15 ml 3 times daily.

Butamirate Citrate pediatric drops:

• Children ( 2 months- 1 yrs): 0.50 ml 4 times daily.
• Children (1-3 yrs): 0.75 ml 4 times daily.

Tolerance of Butamirate Citrate is good.Adverse reactions such as rash,nausea,diarrhoea and vertigo have been observed in a few rare cases,resolving after dose reduction or treatment withdrawal.

Hypersensitivity to the active ingredient.

Butamirate Citrate suppresses the cough reflex and therefore the concomitant use with expectorants should be avoided, since it may lead to mucus retention in the airways, which increases the risk of bronchospasm and respiratory infections. If the cough persists for more than 7 days (more than 3 days in children younger than12 years of age) doctor must be consulted.

Concomitant use with expectorants should be avoided.

Butamirate Citrate should not be used during the first trimester of pregnancy. During the remainder of pregnancy, it can be used if indicated by a physician but with caution. As a general rule, for safety reasons, in the absence of data on elimination of the active substance in breast milk, the benefits of Butamirate Citrate administration during breast feeding should be carefully weighed against the risks.

Accidental overdose with Butamirate Citrate can cause the following symptoms: drowsiness, nausea, vomiting, diarrhoea, loss of balance and hypotension. Standard emergency procedures should be followed: activated charcoal, saline laxatives and standard cardio-respiratory resuscitation.

Keep away from light and moisture, store below 30°C. Keep all the medicines out of the reach of children.

Cough suppressant

Butamirate Citrate acts directly on the brain's cough center to suppress cough. Butamirate Citrate is safe and non-sedating which is neither chemically nor pharmacologically related to opium alkaloids. Butamirate Citrate is rapidly and completely absorbed after oral administration. Maximum concentration is reached within 9 hours with the sustained-release tablet. This is extremely protein-bound and plasma elimination half-life is about 13 hours. The active metabolites of Butamirate Citrate have also antitussive action.

Use in adult:

• Butamirate Citrate 50 mg tablet: 2-3 tablets daily.
• Butamirate Citrate syrup: 15 ml 4 times daily.

Use in children & adolescents:
Butamirate Citrate 50 mg tablet:

• Adolescent over 12 years old: 1-2 tablets daily.

Butamirate Citrate syrup:

• Children (3-6 yrs): 5 ml 3 times daily.
• Children (6-12 yrs): 10 ml 3 times daily.
• Adolescent: 15 ml 3 times daily.

Butamirate Citrate pediatric drops:

• Children ( 2 months- 1 yrs): 0.50 ml 4 times daily.
• Children (1-3 yrs): 0.75 ml 4 times daily.

Tolerance of Butamirate Citrate is good.Adverse reactions such as rash,nausea,diarrhoea and vertigo have been observed in a few rare cases,resolving after dose reduction or treatment withdrawal.

Hypersensitivity to the active ingredient.

Butamirate Citrate suppresses the cough reflex and therefore the concomitant use with expectorants should be avoided, since it may lead to mucus retention in the airways, which increases the risk of bronchospasm and respiratory infections. If the cough persists for more than 7 days (more than 3 days in children younger than12 years of age) doctor must be consulted.

Concomitant use with expectorants should be avoided.

Butamirate Citrate should not be used during the first trimester of pregnancy. During the remainder of pregnancy, it can be used if indicated by a physician but with caution. As a general rule, for safety reasons, in the absence of data on elimination of the active substance in breast milk, the benefits of Butamirate Citrate administration during breast feeding should be carefully weighed against the risks.

Accidental overdose with Butamirate Citrate can cause the following symptoms: drowsiness, nausea, vomiting, diarrhoea, loss of balance and hypotension. Standard emergency procedures should be followed: activated charcoal, saline laxatives and standard cardio-respiratory resuscitation.

Keep away from light and moisture, store below 30°C. Keep all the medicines out of the reach of children.

Cough suppressant

Butamirate Citrate acts directly on the brain's cough center to suppress cough. Butamirate Citrate is safe and non-sedating which is neither chemically nor pharmacologically related to opium alkaloids. Butamirate Citrate is rapidly and completely absorbed after oral administration. Maximum concentration is reached within 9 hours with the sustained-release tablet. This is extremely protein-bound and plasma elimination half-life is about 13 hours. The active metabolites of Butamirate Citrate have also antitussive action.

Use in adult:

• Butamirate Citrate 50 mg tablet: 2-3 tablets daily.
• Butamirate Citrate syrup: 15 ml 4 times daily.

Use in children & adolescents:
Butamirate Citrate 50 mg tablet:

• Adolescent over 12 years old: 1-2 tablets daily.

Butamirate Citrate syrup:

• Children (3-6 yrs): 5 ml 3 times daily.
• Children (6-12 yrs): 10 ml 3 times daily.
• Adolescent: 15 ml 3 times daily.

Butamirate Citrate pediatric drops:

• Children ( 2 months- 1 yrs): 0.50 ml 4 times daily.
• Children (1-3 yrs): 0.75 ml 4 times daily.

Tolerance of Butamirate Citrate is good.Adverse reactions such as rash,nausea,diarrhoea and vertigo have been observed in a few rare cases,resolving after dose reduction or treatment withdrawal.

Hypersensitivity to the active ingredient.

Butamirate Citrate suppresses the cough reflex and therefore the concomitant use with expectorants should be avoided, since it may lead to mucus retention in the airways, which increases the risk of bronchospasm and respiratory infections. If the cough persists for more than 7 days (more than 3 days in children younger than12 years of age) doctor must be consulted.

Concomitant use with expectorants should be avoided.

Butamirate Citrate should not be used during the first trimester of pregnancy. During the remainder of pregnancy, it can be used if indicated by a physician but with caution. As a general rule, for safety reasons, in the absence of data on elimination of the active substance in breast milk, the benefits of Butamirate Citrate administration during breast feeding should be carefully weighed against the risks.

Accidental overdose with Butamirate Citrate can cause the following symptoms: drowsiness, nausea, vomiting, diarrhoea, loss of balance and hypotension. Standard emergency procedures should be followed: activated charcoal, saline laxatives and standard cardio-respiratory resuscitation.

Keep away from light and moisture, store below 30°C. Keep all the medicines out of the reach of children.

হায়োসিন বিউটাইলব্রোমাইড একটি এন্টিকোলিনার্জিক ওষুধ, এবডোমিনাল ক্যাভিটির বিভিন্ন অংশের নরম মাংসপেশীর (smooth muscle) উপর যার খিঁচুনিবিরোধী (antispasmodic) ক্রিয়া রয়েছে। হায়োসিন বিউটাইলব্রোমাইড ট্যাবলেট গ্যাসট্রো ইন্টেসটিনাল ট্র্যাক্টে অথবা জেনিটো-ইউরিনারী ট্র্যাক্টের ভিসেরাল খিঁচুনি জনিত লক্ষণসমূহে নির্দেশিত। স্পাসমোডিক ডিসমেনোরিয়াতেও এটি নির্দেশিত। হায়োসিন বিউটাইলব্রোমাইড ইনজেকশন গ্যাসট্রো-ইন্টেসটিনাল খিঁচুনি এবং রেনাল অথবা পিত্তের (billary) তীব্র ব্যথাতেও নির্দেশিত। রেডিওলজীতে প্রতিবন্ধকতার পার্থক্যমূলক রোগ নির্ণয়ে, পাইলোগ্রাফীতে খিঁচুনি ও ব্যথা কমাতে এবং গ্যাসট্রো-ডিওডেনাল এনডোস্কোপীর মত রোগ নির্ণয়ের অন্যান্য পদ্ধতিতেও খিঁচুনির সমস্যা দূর করার জন্য হায়োসিন বিউটাইলব্রোমাইড ইনজেকশন ব্যবহার করা হয়।

Anticholinergics (antimuscarinics)/ Anti-spasmodics

খাওয়ার জন্য-

• প্রাপ্ত বয়স্ক: ২০ মিগ্রা দিনে চার বার। স্পাসমোডিক ডিসমেনোরিয়ার ক্ষেত্রে ঋতুস্রাব (menstruation) শুরুর সম্ভাব্য তারিখের কমপক্ষে দুদিন আগে থেকে চিকিৎসা শুরু করতে হবে এবং স্রাব শুরুর তিনদিন পরে পর্যন্ত তা অব্যাহত রাখতে হবে।
• শিশু ৬ থেকে ১২ বৎসর পর্যন্ত: ১০ মিগ্রা দিনে তিনবার অথবা চিকিৎসকের নির্দেশ অনুযায়ী। 

ইনজেকশন হিসেবে-

• প্রাপ্তবয়স্ক: মাংসপেশীতে বা শিরাপথে প্রয়োগের জন্য সাধারণ মাত্রা হচ্ছে ২০ মিগ্রা (১টি এ্যাম্পুল), প্রয়োজনে যা কিনা ৩০ মিনিট পর পুনরায় প্রয়োগ করতে হবে। এনডোস্কোপীর ক্ষেত্রে এই মাত্রা আরো ঘন ঘন প্রয়োগ করতে হবে।

হায়োসিন বিউটাইলব্রোমাইড এর পার্শ্ব-প্রতিক্রিয়ার মধ্যে রয়েছে মুখ শুকিয়ে যাওয়া, পিউপিল এর প্রসরণ (dilatation), ইন্ট্রা-অকিউলার প্রেসার বৃদ্ধি, ফ্লাসিং, ত্বক শুকিয়ে যাওয়া, ব্র্যাডিকার্ডিয়া এবং তারপরেই ট্যাকিকার্ডিয়া ও এরিমিয়া। কখনো কখনো ক্লান্তি, বমি, মাথা ঝিমঝিম (giddiness) এবং ষ্ট্যাগারিং হতে পারে।

যে সব রোগীর প্রস্টেটিক বৃদ্ধি ঘটেছে তাদের ক্ষেত্রে এর ব্যবহার নিষিদ্ধ এবং বৃদ্ধদের ক্ষেত্রে এটি সতর্কতার সাথে ব্যবহার করতে হবে। যে সব রোগী প্যারালাইটিক ইলিয়াস অথবা পাইলোরিক ষ্টেনোসিসে ভুগছেন তাদের ক্ষেত্রেও ওষুধটির ব্যবহার নিষিদ্ধ। সম্ভাব্য মাইড্রিয়াটিক ক্ষতির কারণে যে সব রোগীর গ্লুকোমা রয়েছে তাদের ক্ষেত্রেও এটির ব্যবহার নিষিদ্ধ ।

সাবধানতা: হায়োসিন ঝিমুনি সৃষ্টি করতে পারে ও মানসিক সতর্কতা নিজে করে নিস্তেজ করে দিতে পারে। যে সকল রোগী হায়োসিন দিয়ে চিকিৎসাধীন রয়েছে তাদের গাড়ী বা অন্যান্য যানবাহন অথবা মানসিক একাগ্রতার অভাবে দুর্ঘটনা ঘটতে পারে এমন কোন যন্ত্রপাতি চালানো উচিত নয়। রোগীদের মদ্যপান করা থেকেও বিরত থাকা উচিত।

সতর্কতা: থাইরোটক্সিকোসিস, কার্ডিয়াক অপর্যাপ্ততা (insufficiency) বা ফেলিওর এবং হৃদপিন্ডে অস্ত্রোপচারের ক্ষেত্রে এই ওষুধ হৃদপিন্ডের গতি আরো বাড়িয়ে দিতে পারে বলে এর ব্যবহারে সতর্কতা অবলম্বন করা উচিত। অন্যান্য এন্টিকোলিনার্জিক ওষুধসমূহ যেমন এমানটেডিন, কোন কোন এন্টিহিস্টামিন, বিউটাইরোফেনন ও ফেনোথায়াজিন এবং ট্রাইসাইক্লিক এন্টিডিপ্রেসেন্ট হায়োসিনের সাথে একত্রে প্রয়োগের ফলে হায়োসিনের ক্রিয়া বেড়ে যেতে পারে বিধায় এ সব ক্ষেত্রে হায়োসিন ব্যবহার করতে হলে এর মাত্রা কমিয়ে নেয়া প্রয়োজন হতে পারে।

গর্ভাবস্থার প্রথম তিন মাসে অন্যান্য ওষুধের মতো একেও সতর্কতার সাথে ব্যবহার করতে হবে।

ডেক্সট্রান কিংবা ০.৯% সোডিয়াম ক্লোরাইড ইনজেকশনের তরল দিয়ে হায়োসিন বিউটাইলব্রোমাইড ইনজেকশনকে তরলীকরণ করা যাবে।

মেয়াদ উত্তীর্ণের পর ব্যবহার করবেন না। সকল ওষুধ শিশুদের নাগালের বাইরে রাখুন।  কেবলমাত্র রেজিস্টার্ড চিকিৎসকের ব্যবস্থাপত্র অনুযায়ী বিতরণযোগ্য।

Butenafine cream is indicated for the topical treatment of the following superficial dermatophytosis: Interdigital tinea pedis (athlete's foot); Tinea corporis (ringworm); Tinea cruris (jock itch) due to E. floccosum, T. mentagrophytes, T. rubrum, and T. tonsurans.

Topical Antifungal preparations

Butenafine is a synthetic antifungal agent that is structurally and pharmacologically related to allylamine antifungals. The exact mechanism of action has not been established, but it is suggested that butenafine's antifungal activity is exerted through the alteration of cellular membranes, which results in increased membrane permeability, and growth inhibition.

Butenafine is mainly active against dermatophytes and has superior fungicidal activity against this group of fungi when compared to that of terbinafine, naftifine, tolnaftate, clotrimazole, and bifonazole. It is also active against Candida albicans and this activity is superior to that of terbinafine and naftifine. Butenafine also generates low MICs for Cryptococcus neoformans and Aspergillus spp. as well.

In the treatment of interdigital tinea pedis, Butenafine should be applied twice daily for 7 days or once daily for 4 weeks. Patients with tinea corporis or tinea cruris should apply Butenafine once daily for two weeks. Sufficient Butenafine cream should be applied to cover affected areas and immediately surrounding skin of patients with interdigital tinea pedis, tinea corporis and tinea cruris.

Rarely local mild burning or irritation may be experienced. Hypersensitivity reactions may occur.

Butenafine Hydrochloride is contraindicated in individuals who have known or suspected sensitivity to this cream or any of its components.

Butenafine cream is not for ophthalmic, oral, or intravaginal use. This is for external use only. If irritation or sensitivity develops with the use of Butenafine cream, treatment should be discontinued and appropriate therapy instituted.

Potential drug interactions between butenafine HCl cream and other drugs have not been evaluated.

Pregnancy Category C. As no adequate and well-controlled studies have been conducted, this drug should be used during pregnancy only if clearly needed. It is not known if butenafine HCl is excreted in human milk. Caution should be exercised in prescribing butenafine HCl to a nursing woman.

Safety and efficacy in pediatric patients below the age of 12 years have not been studied.

Overdosage of butenafine HCl in humans has not been reported to date.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Bambuterol is indicated for Bronchial asthma, chronic bronchitis, emphysema & other lung diseases where bronchospasm is a complicating factor.

Short-acting selective & β2-adrenoceptor stimulants

Bambuterol is an adrenergic β2 receptor agonist which predominantly stimulates β2 receptor, thus producing relaxation of bronchial smooth muscle, inhibition of release of endogenous spasmogens, inhibition of edema caused by endogenous mediators & increased mucocilliary clearance.

Adult or Elderly: The recommended initial dose 10 mg. The dose may be increased to 20 mg after 1-2 weeks depending on the clinical effect.

Children 2-5 years: The recommended normal dose 10 mg (10 ml syrup).

Children 6-12 years: The recommended normal dose 10 mg (10 ml syrup). The dose may be increased to 20 mg.

Common side effects are fatigue, nausea, palpitation, headache, dizziness & tremor.

Bambuterol is contraindicated in hepatic impairment, liver cirrhosis or severely impaired liver function.

Reduce the dose in renal impairment, avoid in cirrhosis and severe hepatic impairment. Caution should be observed in patients with severe cardiovascular disorder, such as ischaemic heart disease, tachyarrhythmias or severe heart failure.

Succinylcholin, MAOIs (monoamine oxidase inhibitors), β2-blockers, corticosteroids, diuretics, muscle relaxants, sympathomimetic xanthine derivatives. Bambuterol may partly or totally inhibit the effect of β-blockers.

Pregnant women: There is no definite evidence of ill consequence during pregnancy. Nevertheless, the drug should not be used during the first trimester of pregnancy, unless the expected benefit is thought to outweigh any possible risk to the fetus.

Lactating mother: It is excreted in breast milk. So, patients taking this drug should not breast-feed.

Impaired renal function (GFR 50 ml/min): The recommended starting dose is 5 mg, which may be increased to 10 mg after one to two weeks, depending on the clinical effect.

Impaired hepatic function: Not recommended because of unpredictable conversion to terbutaline.

Keep away from light, store in a cool and dry place. Keep out of reach of children.

Bambuterol is indicated for Bronchial asthma, chronic bronchitis, emphysema & other lung diseases where bronchospasm is a complicating factor.

Short-acting selective & β2-adrenoceptor stimulants

Bambuterol is an adrenergic β2 receptor agonist which predominantly stimulates β2 receptor, thus producing relaxation of bronchial smooth muscle, inhibition of release of endogenous spasmogens, inhibition of edema caused by endogenous mediators & increased mucocilliary clearance.

Adult or Elderly: The recommended initial dose 10 mg. The dose may be increased to 20 mg after 1-2 weeks depending on the clinical effect.

Children 2-5 years: The recommended normal dose 10 mg (10 ml syrup).

Children 6-12 years: The recommended normal dose 10 mg (10 ml syrup). The dose may be increased to 20 mg.

Common side effects are fatigue, nausea, palpitation, headache, dizziness & tremor.

Bambuterol is contraindicated in hepatic impairment, liver cirrhosis or severely impaired liver function.

Reduce the dose in renal impairment, avoid in cirrhosis and severe hepatic impairment. Caution should be observed in patients with severe cardiovascular disorder, such as ischaemic heart disease, tachyarrhythmias or severe heart failure.

Succinylcholin, MAOIs (monoamine oxidase inhibitors), β2-blockers, corticosteroids, diuretics, muscle relaxants, sympathomimetic xanthine derivatives. Bambuterol may partly or totally inhibit the effect of β-blockers.

Pregnant women: There is no definite evidence of ill consequence during pregnancy. Nevertheless, the drug should not be used during the first trimester of pregnancy, unless the expected benefit is thought to outweigh any possible risk to the fetus.

Lactating mother: It is excreted in breast milk. So, patients taking this drug should not breast-feed.

Impaired renal function (GFR 50 ml/min): The recommended starting dose is 5 mg, which may be increased to 10 mg after one to two weeks, depending on the clinical effect.

Impaired hepatic function: Not recommended because of unpredictable conversion to terbutaline.

Keep away from light, store in a cool and dry place. Keep out of reach of children.

Third generation Cephalosporins

Ceftibuten is the dihydrate salt of Ceftibuten, is a semi-synthetic Cephalosporin antibiotic for oral administration. Ceftibuten exerts its bactericidal action by binding to essential target proteins of the bacterial cell wall. This binding leads to inhibition of cell-wall synthesis.

Otitis Media-

• Adult Dosage: 400 mg orally every 24 hours for 10 days
• Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Tonsillitis/Pharyngitis-

• Adult Dosage: 400 mg orally every 24 hours for 10 days
• Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Bronchitis-

• Adult Dosage: 400 mg orally every 24 hours for 10 days
• Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 10 days

Cystitis-

• Adult Dosage: 400 mg orally every 24 hours for 7 days
• Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 7 days

Pneumonia-

• Adult Dosage: 200 mg orally every 12 hours for 7 to 14 days
• Pediatric Dosage: >12 years: 200 mg orally every 12 hours for 7 to 14 days

Sinusitis-

• Adult Dosage: 400 mg orally every 24 hours for 10 to 14 days
• Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 10 to 14 days

Urinary tract Infection-

• Adult Dosage: 400 mg orally every 24 hours for 10 days
• Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Nausea, headache, diarrhea, dyspepsia, dizziness, abdominal pain, vomiting.

Ceftibuten is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

As with other broad-spectrum antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Careful observation of the patient is essential. The dose of Ceftibuten may require adjustment in patients with varying degrees of renal insufficiency. Ceftibuten should be prescribed with caution to individuals with a history of gastrointestinal disease, particularly colitis.

Theophylline & Antacid do not alter the pharmacokinetic profile of Ceftibuten. Ranitidine increases the Cmax & AUC of Ceftibuten.

Pregnancy Category B. There are no controlled data on the use of Ceftibuten in pregnant women. Ceftibuten should be used in pregnancy only when the benefit clearly outweighs the risk. It is not known whether Ceftibuten (recommended dosage) is excreted in human milk. Because many drugs are excreted in human milk, caution should be excercised when Ceftibuten is administered to nursing women.

Renal Impairment-

• CrCl 5 to 29 ml/min: 2.25 mg/kg or 100 mg orally once a day
• CrCl 30 to 49 ml/min: 4.5 mg/kg or 200 mg orally once a day

Hepatic Impairment: Dose adjustment is not necessary.

• The small bottle contains purified water and large bottle contains granules
• Pour the purified water completely into large bottle 
• Tighten the cap of large bottle and shake the bottle for at least one minute
• Use a measuring cup or dropper for reconstituted suspension

Prepared suspension to be consumed within 14 days of preparation if kept in a refrigerator. Shake the bottle well each time before use.

Store below 25°C, protected from light and moisture. For Suspension: After reconstitution, the suspension may be used for 14 days while stored at 2° to 8°C. Keep out of reach of children.

Third generation Cephalosporins

Ceftibuten is the dihydrate salt of Ceftibuten, is a semi-synthetic Cephalosporin antibiotic for oral administration. Ceftibuten exerts its bactericidal action by binding to essential target proteins of the bacterial cell wall. This binding leads to inhibition of cell-wall synthesis.

Otitis Media-

• Adult Dosage: 400 mg orally every 24 hours for 10 days
• Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Tonsillitis/Pharyngitis-

• Adult Dosage: 400 mg orally every 24 hours for 10 days
• Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Bronchitis-

• Adult Dosage: 400 mg orally every 24 hours for 10 days
• Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 10 days

Cystitis-

• Adult Dosage: 400 mg orally every 24 hours for 7 days
• Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 7 days

Pneumonia-

• Adult Dosage: 200 mg orally every 12 hours for 7 to 14 days
• Pediatric Dosage: >12 years: 200 mg orally every 12 hours for 7 to 14 days

Sinusitis-

• Adult Dosage: 400 mg orally every 24 hours for 10 to 14 days
• Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 10 to 14 days

Urinary tract Infection-

• Adult Dosage: 400 mg orally every 24 hours for 10 days
• Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Nausea, headache, diarrhea, dyspepsia, dizziness, abdominal pain, vomiting.

Ceftibuten is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

As with other broad-spectrum antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Careful observation of the patient is essential. The dose of Ceftibuten may require adjustment in patients with varying degrees of renal insufficiency. Ceftibuten should be prescribed with caution to individuals with a history of gastrointestinal disease, particularly colitis.

Theophylline & Antacid do not alter the pharmacokinetic profile of Ceftibuten. Ranitidine increases the Cmax & AUC of Ceftibuten.

Pregnancy Category B. There are no controlled data on the use of Ceftibuten in pregnant women. Ceftibuten should be used in pregnancy only when the benefit clearly outweighs the risk. It is not known whether Ceftibuten (recommended dosage) is excreted in human milk. Because many drugs are excreted in human milk, caution should be excercised when Ceftibuten is administered to nursing women.

Renal Impairment-

• CrCl 5 to 29 ml/min: 2.25 mg/kg or 100 mg orally once a day
• CrCl 30 to 49 ml/min: 4.5 mg/kg or 200 mg orally once a day

Hepatic Impairment: Dose adjustment is not necessary.

• The small bottle contains purified water and large bottle contains granules
• Pour the purified water completely into large bottle 
• Tighten the cap of large bottle and shake the bottle for at least one minute
• Use a measuring cup or dropper for reconstituted suspension

Prepared suspension to be consumed within 14 days of preparation if kept in a refrigerator. Shake the bottle well each time before use.

Store below 25°C, protected from light and moisture. For Suspension: After reconstitution, the suspension may be used for 14 days while stored at 2° to 8°C. Keep out of reach of children.

Third generation Cephalosporins

Ceftibuten is the dihydrate salt of Ceftibuten, is a semi-synthetic Cephalosporin antibiotic for oral administration. Ceftibuten exerts its bactericidal action by binding to essential target proteins of the bacterial cell wall. This binding leads to inhibition of cell-wall synthesis.

Otitis Media-

• Adult Dosage: 400 mg orally every 24 hours for 10 days
• Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Tonsillitis/Pharyngitis-

• Adult Dosage: 400 mg orally every 24 hours for 10 days
• Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Bronchitis-

• Adult Dosage: 400 mg orally every 24 hours for 10 days
• Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 10 days

Cystitis-

• Adult Dosage: 400 mg orally every 24 hours for 7 days
• Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 7 days

Pneumonia-

• Adult Dosage: 200 mg orally every 12 hours for 7 to 14 days
• Pediatric Dosage: >12 years: 200 mg orally every 12 hours for 7 to 14 days

Sinusitis-

• Adult Dosage: 400 mg orally every 24 hours for 10 to 14 days
• Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 10 to 14 days

Urinary tract Infection-

• Adult Dosage: 400 mg orally every 24 hours for 10 days
• Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Nausea, headache, diarrhea, dyspepsia, dizziness, abdominal pain, vomiting.

Ceftibuten is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

As with other broad-spectrum antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Careful observation of the patient is essential. The dose of Ceftibuten may require adjustment in patients with varying degrees of renal insufficiency. Ceftibuten should be prescribed with caution to individuals with a history of gastrointestinal disease, particularly colitis.

Theophylline & Antacid do not alter the pharmacokinetic profile of Ceftibuten. Ranitidine increases the Cmax & AUC of Ceftibuten.

Pregnancy Category B. There are no controlled data on the use of Ceftibuten in pregnant women. Ceftibuten should be used in pregnancy only when the benefit clearly outweighs the risk. It is not known whether Ceftibuten (recommended dosage) is excreted in human milk. Because many drugs are excreted in human milk, caution should be excercised when Ceftibuten is administered to nursing women.

Renal Impairment-

• CrCl 5 to 29 ml/min: 2.25 mg/kg or 100 mg orally once a day
• CrCl 30 to 49 ml/min: 4.5 mg/kg or 200 mg orally once a day

Hepatic Impairment: Dose adjustment is not necessary.

• The small bottle contains purified water and large bottle contains granules
• Pour the purified water completely into large bottle 
• Tighten the cap of large bottle and shake the bottle for at least one minute
• Use a measuring cup or dropper for reconstituted suspension

Prepared suspension to be consumed within 14 days of preparation if kept in a refrigerator. Shake the bottle well each time before use.

Store below 25°C, protected from light and moisture. For Suspension: After reconstitution, the suspension may be used for 14 days while stored at 2° to 8°C. Keep out of reach of children.

Third generation Cephalosporins

Ceftibuten is the dihydrate salt of Ceftibuten, is a semi-synthetic Cephalosporin antibiotic for oral administration. Ceftibuten exerts its bactericidal action by binding to essential target proteins of the bacterial cell wall. This binding leads to inhibition of cell-wall synthesis.

Otitis Media-

• Adult Dosage: 400 mg orally every 24 hours for 10 days
• Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Tonsillitis/Pharyngitis-

• Adult Dosage: 400 mg orally every 24 hours for 10 days
• Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Bronchitis-

• Adult Dosage: 400 mg orally every 24 hours for 10 days
• Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 10 days

Cystitis-

• Adult Dosage: 400 mg orally every 24 hours for 7 days
• Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 7 days

Pneumonia-

• Adult Dosage: 200 mg orally every 12 hours for 7 to 14 days
• Pediatric Dosage: >12 years: 200 mg orally every 12 hours for 7 to 14 days

Sinusitis-

• Adult Dosage: 400 mg orally every 24 hours for 10 to 14 days
• Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 10 to 14 days

Urinary tract Infection-

• Adult Dosage: 400 mg orally every 24 hours for 10 days
• Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Nausea, headache, diarrhea, dyspepsia, dizziness, abdominal pain, vomiting.

Ceftibuten is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

As with other broad-spectrum antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Careful observation of the patient is essential. The dose of Ceftibuten may require adjustment in patients with varying degrees of renal insufficiency. Ceftibuten should be prescribed with caution to individuals with a history of gastrointestinal disease, particularly colitis.

Theophylline & Antacid do not alter the pharmacokinetic profile of Ceftibuten. Ranitidine increases the Cmax & AUC of Ceftibuten.

Pregnancy Category B. There are no controlled data on the use of Ceftibuten in pregnant women. Ceftibuten should be used in pregnancy only when the benefit clearly outweighs the risk. It is not known whether Ceftibuten (recommended dosage) is excreted in human milk. Because many drugs are excreted in human milk, caution should be excercised when Ceftibuten is administered to nursing women.

Renal Impairment-

• CrCl 5 to 29 ml/min: 2.25 mg/kg or 100 mg orally once a day
• CrCl 30 to 49 ml/min: 4.5 mg/kg or 200 mg orally once a day

Hepatic Impairment: Dose adjustment is not necessary.

• The small bottle contains purified water and large bottle contains granules
• Pour the purified water completely into large bottle 
• Tighten the cap of large bottle and shake the bottle for at least one minute
• Use a measuring cup or dropper for reconstituted suspension

Prepared suspension to be consumed within 14 days of preparation if kept in a refrigerator. Shake the bottle well each time before use.

Store below 25°C, protected from light and moisture. For Suspension: After reconstitution, the suspension may be used for 14 days while stored at 2° to 8°C. Keep out of reach of children.

Cough suppressant

Butamirate Citrate acts directly on the brain's cough center to suppress cough. Butamirate Citrate is safe and non-sedating which is neither chemically nor pharmacologically related to opium alkaloids. Butamirate Citrate is rapidly and completely absorbed after oral administration. Maximum concentration is reached within 9 hours with the sustained-release tablet. This is extremely protein-bound and plasma elimination half-life is about 13 hours. The active metabolites of Butamirate Citrate have also antitussive action.

Use in adult:

• Butamirate Citrate 50 mg tablet: 2-3 tablets daily.
• Butamirate Citrate syrup: 15 ml 4 times daily.

Use in children & adolescents:
Butamirate Citrate 50 mg tablet:

• Adolescent over 12 years old: 1-2 tablets daily.

Butamirate Citrate syrup:

• Children (3-6 yrs): 5 ml 3 times daily.
• Children (6-12 yrs): 10 ml 3 times daily.
• Adolescent: 15 ml 3 times daily.

Butamirate Citrate pediatric drops:

• Children ( 2 months- 1 yrs): 0.50 ml 4 times daily.
• Children (1-3 yrs): 0.75 ml 4 times daily.

Tolerance of Butamirate Citrate is good.Adverse reactions such as rash,nausea,diarrhoea and vertigo have been observed in a few rare cases,resolving after dose reduction or treatment withdrawal.

Hypersensitivity to the active ingredient.

Butamirate Citrate suppresses the cough reflex and therefore the concomitant use with expectorants should be avoided, since it may lead to mucus retention in the airways, which increases the risk of bronchospasm and respiratory infections. If the cough persists for more than 7 days (more than 3 days in children younger than12 years of age) doctor must be consulted.

Concomitant use with expectorants should be avoided.

Butamirate Citrate should not be used during the first trimester of pregnancy. During the remainder of pregnancy, it can be used if indicated by a physician but with caution. As a general rule, for safety reasons, in the absence of data on elimination of the active substance in breast milk, the benefits of Butamirate Citrate administration during breast feeding should be carefully weighed against the risks.

Accidental overdose with Butamirate Citrate can cause the following symptoms: drowsiness, nausea, vomiting, diarrhoea, loss of balance and hypotension. Standard emergency procedures should be followed: activated charcoal, saline laxatives and standard cardio-respiratory resuscitation.

Keep away from light and moisture, store below 30°C. Keep all the medicines out of the reach of children.

Targeted Cancer Therapy

Ibrutinib is a small-molecule inhibitor of BTK. Ibrutinib forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is a signaling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. BTK’s role in signaling through the B-cell surface receptors results in activation of pathways necessary for B-cell trafficking, chemotaxis, and adhesion. Nonclinical studies show that ibrutinib inhibits malignant B-cell proliferation and survival in vivo as well as cell migration and substrate adhesion in vitro.

Mantle Cell Lymphoma and Marginal Zone Lymphoma: The recommended dose of Ibrutinib for MCL and MZL is 560 mg (four 140 mg capsules) orally once daily until disease progression or unacceptable toxicity.

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Waldenstrom Macroglobulinemia (WM): The recommended dose of Ibrutinib for CLL/SLL and WM is 420 mg (three 140 mg capsules) orally once daily until disease progression or unacceptable toxicity. The recommended dose of Ibrutinib for CLL/SLL when used in combination with bendamustine and rituximab (administered every 28 days for up to 6 cycles) is 420 mg (three 140 mg capsules) orally once daily until disease progression or unacceptable toxicity.

Administer Ibrutinib orally once daily at approximately the same time each day.
Swallow the capsules whole with water. Do not open, break, or chew the capsules.

The following adverse reactions are discussed in more detail in other sections of the labeling: Hemorrhage, Infections, Cytopenias, Atrial Fibrillation, Hypertension, Second Primary Malignancies and Tumor Lysis Syndrome. Additional Important Adverse Reactions: Diarrhea, Visual Disturbance.

Hypersensitivity to the active substance or to any of the excipients.

CYP3A Inhibitors: Co-administration with strong and moderate CYP3A inhibitors should be avoided. If a moderate CYP3A inhibitor must be used, Ibrutinib dose should be reduced 

CYP3A Inducers: Co-administration with strong CYP3A inducers should be avoided

Pregnancy: Ibrutinib, a kinase inhibitor, can cause fetal harm based on findings from animal studies. In animal reproduction studies, administration of Ibrutinib to pregnant rats and rabbits during the period of organogenesis at exposures up to 2-20 times the clinical doses of 420-560 mg daily produced embryofetal toxicity including malformations. If Ibrutinib is used during pregnancy or if the patient becomes pregnant while taking Ibrutinib, the patient should be apprised of the potential hazard to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

Lactation: There is no information regarding the presence of Ibrutinib or its metabolites in human milk, the effects on the breast fed infant, or the effects on milk production.

Pediatric Use: The safety and effectiveness of Ibrutinib in pediatric patients has not been established.

Geriatric Use: Of the 905 patients in clinical studies of Ibrutinib, 62% were ≥ 65 years of age, while 21% were ≥75 years of age. No overall differences in effectiveness were observed between younger and older patients. Anemia (all grades) and Grade 3 or higher pneumonia occurred more frequently among older patients treated with Ibrutinib.

Hepatic Impairment: Ibrutinib is metabolized in the liver. In a hepatic impairment study, data showed an increase in Ibrutinib exposure. The safety of Ibrutinib has not been evaluated in cancer patients with mild to severe hepatic impairment by Child-Pugh criteria. Monitor patients for signs of Ibrutinib toxicity and follow dose modification guidance as needed. It is not recommended to administer Ibrutinib to patients with moderate or severe hepatic impairment.

There is no specific experience in the management of Ibrutinib over dose in patients. One healthy subject experienced reversible Grade 4 hepatic enzyme increases (AST and ALT) after a dose of 1680 mg. Closely monitor patients who ingest more than the recommended dosage and provide appropriate supportive treatment.

Store in a dry place below 30°C, protect from light. Keep out of the reach of children.

Hepatic viral infections (Hepatitis C)

Sofosbuvir is nucleotide analog inhibitor, which specifically inhibits HCV NS5B (non-structural protein 5B) RNA-dependent RNA polymerase. Following intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), sofosbuvir incorporates into HCV RNA by the NS5B polymerase and acts as a chain terminator. More specifically, Sofosbuvir prevents HCV viral replication by binding to the two Mg2+ ions present in HCV NS5B polymerase's GDD active site motif and preventing further replication of HCV genetic material

One 400 mg tablet taken once daily with or without food. Should be used in combination with Ribavirin or in combination with Pegylated Interferon and Ribavirin for the treatment of CHC.

Recommended combination therapy: (HCV Mono-infected and HCV/HIV-1 Co-infected)-

• Genotype 1 or 4: Sofosbuvir + Peginterferon alfa + Ribavirin for 12 weeks
• Genotype 2: Sofosbuvir + Ribavirin for 12 weeks
• Genotype 3: Sofosbuvir + Ribavirin for 24 weeks

Sofosbuvir in combination with Ribavirin for 24 weeks can be considered for CHC patients with genotype 1 infection who are Interferon ineligible

Should be used in combination with Ribavirin for treatment of CHC in patients with hepatocellular carcinoma awaiting liver transplantation for up to 48 weeks or until liver transplantation whichever occurs first

A dose recommendation cannot be made for patients with severe renal impairment or end stage renal disease

The most common adverse events (incidence greater than or equal to 20%, all grades) observed with Sofosbuvir in combination with Ribavirin were fatigue and headache. The most common adverse events observed with Sofosbuvir in combination with Peginterferon alfa and Ribavirin were fatigue, headache, nausea, insomnia, anemia, pruritus, asthenia, rash, decreased appetite, chills, influenza like illness, pyrexia, diarrhea, neutropenia, myalgia, irritability.

When Sofosbivur is used in combination with Ribavirin or Peginterferon alfa/ Ribavirin, the contraindications applicable to those agents are applicable to combination therapies. Sofosbuvir combination treatment with Ribavirin or Peginterferon alfa/Ribavirin is contraindicated in women who are pregnant or may become pregnant and men whose female partners are pregnant, because of the risks for birth defects and fetal death associated with Ribavirin.

Bradycardia with amiodarone co-administration: Serious symptomatic bradycardia may occur in patients taking amiodarone and Sofosbuvir in combination with another direct acting antiviral (DAA), particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Co-administration of amiodarone with Sofosbuvir in combination with another DAA is not recommended. In patients without alternative, viable treatment options, cardiac monitoring is recommended.

Reduced therapeutic effect with drugs that are potent P-gp inducers in the intestine (eg rifampicin, St. John's wort, carbamazepine & phenytoin), modafinil, phenobarb/ oxcarbazepine, rifabutin/ rifapentine. P-gp &/or BCRP inhibitors. May result in serious symptomatic bradycardia when co-administered with amiodarone in combination with another direct acting antiviral.

Pregnancy Category B: Sofosbuvir There are no adequate and well-controlled studies with Sofosbuvir in pregnant women.

Nursing Mothers: It is not known whether Sofosbuvir and its metabolites are present in human breast milk.

Pediatric Use: Safety and effectiveness of Sofosbuvir in children less than 18 years of age have not been established.

Geriatric Use: Sofosbuvir was administered to 90 subjects aged 65 and over. The response rates observed for subjects over 65 years of age were similar to that of younger subjects across treatment groups. No dose adjustment of Sofosbuvir is warranted in geriatric patients.

The highest dose of Sofosbuvir is a single dose of Sofosbuvir 1200 mg. No specific antidote is available for overdose treatment. Treatment of overdose with Sofosbuvir consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.

Keep out of the reach of children. Keep in a cool & dry place. Protect from light.

This is indicated for the treatment and prevention of zinc and vitamin B deficiencies.

Specific mineral & vitamin combined preparations

Zinc is vital for many biological functions such as immunity enhancement, wound healing, digestion, reproduction, physical growth and mental development. Zinc supports normal growth and development during pregnancy, childhood, and adolescence. Zinc also has some antioxidant properties. Zinc is used to treat ADHD (Attention Deficit Hyper-activity Disorder) in children. In adult, due to zinc deficiency loss of appetite, poor sense of taste and smell, tendency towards depression, white marks on fingernails, frequent infections, low fertility, prostate problems, mental problems, poor wound healing, a poor immune system, diarrhoea, mental lethargy, rough skin and weight loss may occur.

B-Vitamins are needed to release energy from food. They play an important role in ensuring healthy brain and nerve function, healthy red blood cells formation in children & adults. They are specially needed for healthy growth and development of children. B-Vitamin deficiencies in adult cause profound fatigue and various types of neurologic manifestations, which may include weakness, poor balance, confusion, irritability, memory loss, nervousness, tingling of the limbs and loss of coordination. Additional symptoms of vitamin B deficiency are sleep disturbances, nausea, poor appetite, frequent infections, and skin lesions.

Syrup-

• Adults: 10 ml (2 teaspoonful) 2 to 3 times daily or as recommended by the physician.
• Children: 10 ml (2 teaspoonful) 1 to 3 times daily or as recommended by the physician.
• Infants: 5 ml (1 teaspoonful) 1 to 2 times daily or as recommended by the physician.

Tablet-

• Adults & Children over 30 kg: 1 to 2 tablets 2 to 3 times daily or as recommended by the physician.

This is generally well tolerated. However, a few side effects like nausea, vomiting, diarrhoea & stomach upset may occur. Side effects have been reported with specific vitamins but generally at levels substantially higher than recommended doses.

Vitamin B Complex & Zinc is contraindicated in patients with a known hypersensitivity to any of the ingredients of this product.

In acute renal failure, zinc accumulation may occur, so dosage adjustment is needed. This is not intended for the treatment of severe specific deficiencies.

Concomitant intake of tetracyclines and zinc may decrease the Gl absorption and serum levels of tetracyclines. Similarly concomitant administration of zinc and fluroquinolones may decrease the Gl absorption and serum  levels of some fluroquinolones. Coadministration of Niacin and HMG-CoA reductase inhibitors (eg. lovastatin) may result mayopathy and rhabdomyolysis. Pyridoxine reduces levodopa's effectiveness by increasing its peripheral metabolism. Co-administration of pyridoxine with phenytoin may decrease serum levels of phenytoin.

This is recommended in pregnancy and lactation.

In case of overdosage, initially epigastric pain, diarrhoea and vomiting can occur. In that case, one should seek emergency medical attention. Initially, an emetic should be given and then gastric lavage and general supportive measures should be employed.

Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.

This is indicated for the treatment and prevention of zinc and vitamin B deficiencies.

Specific mineral & vitamin combined preparations

Zinc is vital for many biological functions such as immunity enhancement, wound healing, digestion, reproduction, physical growth and mental development. Zinc supports normal growth and development during pregnancy, childhood, and adolescence. Zinc also has some antioxidant properties. Zinc is used to treat ADHD (Attention Deficit Hyper-activity Disorder) in children. In adult, due to zinc deficiency loss of appetite, poor sense of taste and smell, tendency towards depression, white marks on fingernails, frequent infections, low fertility, prostate problems, mental problems, poor wound healing, a poor immune system, diarrhoea, mental lethargy, rough skin and weight loss may occur.

B-Vitamins are needed to release energy from food. They play an important role in ensuring healthy brain and nerve function, healthy red blood cells formation in children & adults. They are specially needed for healthy growth and development of children. B-Vitamin deficiencies in adult cause profound fatigue and various types of neurologic manifestations, which may include weakness, poor balance, confusion, irritability, memory loss, nervousness, tingling of the limbs and loss of coordination. Additional symptoms of vitamin B deficiency are sleep disturbances, nausea, poor appetite, frequent infections, and skin lesions.

Syrup-

• Adults: 10 ml (2 teaspoonful) 2 to 3 times daily or as recommended by the physician.
• Children: 10 ml (2 teaspoonful) 1 to 3 times daily or as recommended by the physician.
• Infants: 5 ml (1 teaspoonful) 1 to 2 times daily or as recommended by the physician.

Tablet-

• Adults & Children over 30 kg: 1 to 2 tablets 2 to 3 times daily or as recommended by the physician.

This is generally well tolerated. However, a few side effects like nausea, vomiting, diarrhoea & stomach upset may occur. Side effects have been reported with specific vitamins but generally at levels substantially higher than recommended doses.

Vitamin B Complex & Zinc is contraindicated in patients with a known hypersensitivity to any of the ingredients of this product.

In acute renal failure, zinc accumulation may occur, so dosage adjustment is needed. This is not intended for the treatment of severe specific deficiencies.

Concomitant intake of tetracyclines and zinc may decrease the Gl absorption and serum levels of tetracyclines. Similarly concomitant administration of zinc and fluroquinolones may decrease the Gl absorption and serum  levels of some fluroquinolones. Coadministration of Niacin and HMG-CoA reductase inhibitors (eg. lovastatin) may result mayopathy and rhabdomyolysis. Pyridoxine reduces levodopa's effectiveness by increasing its peripheral metabolism. Co-administration of pyridoxine with phenytoin may decrease serum levels of phenytoin.

This is recommended in pregnancy and lactation.

In case of overdosage, initially epigastric pain, diarrhoea and vomiting can occur. In that case, one should seek emergency medical attention. Initially, an emetic should be given and then gastric lavage and general supportive measures should be employed.

Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.

Bilastine is indicated for symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria.

Non-sedating antihistamines

Bilastine is a non-sedating, long-acting histamine antagonist with selective peripheral H 1 receptor antagonist affinity and no affinity for muscarinic receptors. Bilastine inhibits histamine-induced wheal and flare skin reactions for 24 hours following single doses.

Adults & adolescents (12 years of age and over): 20 mg tablet once daily for symptomatic relief of allergic rhinitis, urticaria and allergic rhinoconjunctivitis. The maximum recommended daily dose is 20 mg Bilastine (1 tablet) and should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken. 20 mg Bilastine tablet (1 tablet) once daily should be swallowed with water on an empty stomach to achieve optimal exposure to Bilastine.

Children between 6 to 11 years: 10 mg mouth dissolving tablet for the symptomatic relief of allergic rhinitis, allergic rhinoconjunctivitis and urticaria. The Mouth dissolving tablet is for oral use only. It should be placed in the mouth. It will disperse rapidly in saliva and can be easily swallowed. Alternatively, the mouth dissolving tablet can be dispersed in a tea spoon of water before being swallowed by the children. The maximum recommended daily dose for children in between 6 to 11 years is 10 mg Bilastine mouth dissolving tablet (1 tablet) and should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken.

Children between 2 to 11 years: 4 ml once daily.

The most commonly reported side effects in clinical trial are headache, dizziness, somnolence and fatigue. These adverse events occurred with a comparable frequency in patients receiving placebo.

Bilastine is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients of the tablet.

Co-administration of Bilastine and P-glycoprotein inhibitors (e.g. Ketoconazole, Erythromycin, Cyclosporine, Ritonavir or Diltiazem) should be avoided in patients with moderate or severe renal impairment.

Concomitant intake of Bilastine and Ketoconazole or Erythromycin or Diltiazem increased C max of Bilastine. The psychomotor performance after concomitant intake of alcohol and Bilastine was similar to that observed after intake of alcohol and placebo. Concomitant intake of Bilastine and Lorazepam 3 mg for 8 days did not potentiate the depressant CNS effects of Lorazepam.

There are no or limited amount of data from the use of Bilastine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, parturition or postnatal development. As a precautionary measure, it is preferable to avoid the use of Bilastine during pregnancy. The excretion of Bilastine in milk has not been studied in humans. A decision must be made taking into account the benefit of breast-feeding for the child and the benefit of Bilastine therapy for the mother.

Efficacy and safety of Bilastine in children under 2 years of age have not been established and there is little clinical experience in children aged 2 to 5 years, therefore Bilastine should not be used in these age groups.

In clinical trials, after administration of Bilastine at doses 10 to 11 times the therapeutic dose (220 mg as single dose; or 200 mg/day for 7 days) frequency of treatment-emergent adverse events was two times higher than with placebo. The adverse reactions most frequently reported were dizziness, headache and nausea. No serious adverse events and no significant prolongation in the QTc interval were reported.

Keep below 30°C temperature, protected from light and moisture. Keep out of reach of children.