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Third generation Cephalosporins

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

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

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily
• In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Third generation Cephalosporins

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

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

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily
• In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Third generation Cephalosporins

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

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

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily
• In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Micronized Progesterone is indicated in-

• Luteal phase support as part of an Assisted Reproductive Technology (ART) treatment for women.
• Treatment of premenstrual syndrome, including premenstrual tension and depression.
• Treatment of puerperal depression.

Corticosteroid, Other Topical corticosteroids

Micronized Progesterone Vaginal Pessary is structurally and biologically identical to natural endogenous progesterone.

• Absorption: Vaginal administration of Progesterone 400 mg every 12 h in healthy women has been shown effective in rapidly achieving and maintaining serum progesterone concentrations at physiological levels appropriate to the mid-luteal phase of the ovarian cycle and early pregnancy.
• Distribution: Progesterone is approximately 96 % to 99 % bound to serum proteins, primarily to serum albumin and corticosteroid binding globulin.
• Biotransformation: Progesterone is metabolized primarily by the liver largely to pregnanediols and pregnanolones. Pregnanediols and pregnanolones are conjugated in the liver to glucuronide and sulfate metabolites. Progesterone metabolites that are excreted in the bile may be deconjugated and may be further metabolized in the gut via reduction, dehydroxylation and epimerization.
• Elimination: Progesterone undergoes renal and biliary elimination.

For luteal phase support as part of an ART treatment: 400 mg administered vaginally twice a day starting at oocyte retrieval. The administration of Progesterone should be continued for 38 days, if pregnancy has been confirmed.

For maintenance of Pregnancy in cases of Threatened or recurrent abortion: 200 to 400 mg per day in divided doses.

For the treatment of premenstrual syndrome and puerperal depression: 200 mg daily to 400mg twice a day, by vaginal or rectal insertion. For premenstrual syndrome commence treatment on day 14 of menstrual cycle and continue treatment until onset of menstruation. If symptoms are present at ovulation commence treatment on day 12.

Micronized Progesterone is devoid of estrogenic, androgenic and mineralocorticoid effects. Mild somnolence and other CNS side effects like depression, breast tenderness and bloating are reported. Side effects are less when vaginal route is used.

Micronized Progesterone is not indicated in threatened miscarriage. Treatment should be discontinued in the event of a missed miscarriage. Micronized Progesterone should be discontinued if any of the following conditions are suspected: Myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism (venous thromboembolism or pulmonary embolism), thrombophlebitis or retinal thrombosis.

Drugs known to induce the hepatic cytochrome-P450-3A4 system (e.g. rifampicin, carbamazepine or phenytoin) may increase the elimination rate and thereby decrease the bioavailability of progesterone. The effect of concomitant vaginal products on the exposure of progesterone from Micronized Progesterone has not been assessed and is therefore not recommended.

Renal impaired patient: There is no experience with the use of Progesterone in patients with impaired liver or renal function.

Pediatric population: There is no relevant use of Progesterone in the pediatric population.

Elderly: No clinical data have been collected in patients over age 65.

Keep in a cool (below 30°C), dry and dark place. Keep out of the reach of children.

Drugs for menopausal symptoms: Hormone replacement therapy, Female Sex hormones, Oral Contraceptive preparations

Progesterone softgel capsule contains micronised progesterone, which is structurally and biologically identical to natural endogenous progesterone. Micronisation increases the bioavailability of progesterone. When micronised progesterone is administered after meals, maximal serum progesterone levels are significantly increased. Progesterone concentrations in the endometrial and breast tissue attain high level. Progesterone is approximately 96%-99% bound to serum proteins, primarily to serum albumin (50%-54%). Progesterone is metabolized to pregnanediols and pregnanolones in the liver. The glucuronide and sulfate conjugates of pregnanediol and pregnanolone are excreted in the bile and urine. Progesterone metabolites, which are excreted in bile, may undergo enterohepatic circulation.

The usual recommended dose: Progesterone 100 mg/200 mg 2 to 3 soft gel capsules daily by the oral or vaginal routes in divided doses. Flexible dosage regimen can be followed depending on the indication and requirements of patients.

Maintenance of Pregnancy in cases of Threatened / Recurrent abortion: Progesterone 200 to 400 mg per day in divided doses.

In-vitro fertilization and embryo transfer: Progesterone 200 mg thrice a day from the day of embryo transfer till pregnancy is confirmed. If pregnant, it is continued till 12^th week of pregnancy.

HRT: In sequential regimen: Progesterone 200mg daily for 12 days in last 2 weeks of each therapeutic cycle. In continuous regimen: Progesterone 100 mg daily throughout the month along with estrogen.

Oocyte donation program: Progesterone 100mg twice daily from the day of transfer till pregnancy is confirmed. This may be increased to a maximum of 600 mg per day and continued till 12^th week of pregnancy.

Luteal support: Progesterone 100 mg thrice a day from the 17^th day of the cycle for 10 days in induced cycle. If pregnant, it is continued till 12^th week of pregnancy.

Luteal phase insufficiency: Progesterone 100 mg thrice daily to be continued up to 12 weeks of pregnancy, increasing the dose by 100 mg/day/week to a maximum of 600 mg/day in divided doses if required.

In secondary amenorrhoea: Progesterone 300mg for 10 days results in withdrawal bleeding in 80% of cases.

Premenstrual syndrome: Progesterone 100-200 mg daily for 10 days from 17^th to 26^th day of each menstrual cycle.

Benign mastopathy: Progesterone 200-300 mg for 10 days per month, usually from 17^th to 26^th day of the monthly cycle.

Progesterone is devoid of estrogenic, androgenic and mineralocorticoid effects. Mild somnolence and other CNS side effects like depression, breast tenderness and bloating are reported. Side effects are less when vaginal route is used.

Hypersensitivity, hepatic dysfunction, undiagnosed vaginal bleeding, porphyria, cancers of uterus and genital organs, breast cancers, history of stroke or blood clots. It should not be used in a case of miscarriage and tissue left in the uterus.

Severe renal insufficiency, diabetes mellitus, seizures, migraine, headache, heart diseases, depression.

Ketoconazole inhibits the metabolism of progesterone.

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

Drugs for menopausal symptoms: Hormone replacement therapy, Female Sex hormones, Oral Contraceptive preparations

Progesterone softgel capsule contains micronised progesterone, which is structurally and biologically identical to natural endogenous progesterone. Micronisation increases the bioavailability of progesterone. When micronised progesterone is administered after meals, maximal serum progesterone levels are significantly increased. Progesterone concentrations in the endometrial and breast tissue attain high level. Progesterone is approximately 96%-99% bound to serum proteins, primarily to serum albumin (50%-54%). Progesterone is metabolized to pregnanediols and pregnanolones in the liver. The glucuronide and sulfate conjugates of pregnanediol and pregnanolone are excreted in the bile and urine. Progesterone metabolites, which are excreted in bile, may undergo enterohepatic circulation.

The usual recommended dose: Progesterone 100 mg/200 mg 2 to 3 soft gel capsules daily by the oral or vaginal routes in divided doses. Flexible dosage regimen can be followed depending on the indication and requirements of patients.

Maintenance of Pregnancy in cases of Threatened / Recurrent abortion: Progesterone 200 to 400 mg per day in divided doses.

In-vitro fertilization and embryo transfer: Progesterone 200 mg thrice a day from the day of embryo transfer till pregnancy is confirmed. If pregnant, it is continued till 12^th week of pregnancy.

HRT: In sequential regimen: Progesterone 200mg daily for 12 days in last 2 weeks of each therapeutic cycle. In continuous regimen: Progesterone 100 mg daily throughout the month along with estrogen.

Oocyte donation program: Progesterone 100mg twice daily from the day of transfer till pregnancy is confirmed. This may be increased to a maximum of 600 mg per day and continued till 12^th week of pregnancy.

Luteal support: Progesterone 100 mg thrice a day from the 17^th day of the cycle for 10 days in induced cycle. If pregnant, it is continued till 12^th week of pregnancy.

Luteal phase insufficiency: Progesterone 100 mg thrice daily to be continued up to 12 weeks of pregnancy, increasing the dose by 100 mg/day/week to a maximum of 600 mg/day in divided doses if required.

In secondary amenorrhoea: Progesterone 300mg for 10 days results in withdrawal bleeding in 80% of cases.

Premenstrual syndrome: Progesterone 100-200 mg daily for 10 days from 17^th to 26^th day of each menstrual cycle.

Benign mastopathy: Progesterone 200-300 mg for 10 days per month, usually from 17^th to 26^th day of the monthly cycle.

Progesterone is devoid of estrogenic, androgenic and mineralocorticoid effects. Mild somnolence and other CNS side effects like depression, breast tenderness and bloating are reported. Side effects are less when vaginal route is used.

Hypersensitivity, hepatic dysfunction, undiagnosed vaginal bleeding, porphyria, cancers of uterus and genital organs, breast cancers, history of stroke or blood clots. It should not be used in a case of miscarriage and tissue left in the uterus.

Severe renal insufficiency, diabetes mellitus, seizures, migraine, headache, heart diseases, depression.

Ketoconazole inhibits the metabolism of progesterone.

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

The benefits of taking the pill include:

• It is one of the most reliable reversible methods of contraception if used correctly
• It does not interrupt sex
• It usually makes period regular, lighter and less painful
• It may help with pre-menstrual symptoms

Oral Contraceptive preparations

Take this tablet every day for 21 days as described below: This tablet comes in strips of 21 pills, each marked with a day of the week.

• Take your pill at the same time every day.
• Start by taking a pill marked with the correct day of the week.
• Follow the direction of the arrows on the strip. Take one pill each day, until you have finished all 21 pills.
• Swallow each pill whole, with water if necessary. Do not chew the pill.
• After you have taken all 21 pills in the strip, you have seven days when you take no pills. So, if you take the last pill of one pack on a Friday, you will take the first pill of your next pack on the Saturday of the following week.

Within a few days of taking the last pill from the strip, you should have a withdrawal bleed like a period. This bleed may not have finished when it is time to start your next strip of pills.

You don't need to use extra contraception during these seven pill-free days.

Starting this tablet:

• As a new user icrolon or starting the pill again after a break. Either take your first pill on the first day of your next period. By starting in this way, you will have contraceptive protection with your first pill.
• Or if your period has already begun start taking this tablet on day 5 (counting the first day of your period as day 1) whether or not your bleeding has stopped. You must also use extra contraception, such as condoms, until you have taken the first seven pills correctly.

Changing to this pill from another contraceptive Pill-

• If you are currently on a 21-day pill, start taking jUicrolon the next day after the end of the previous strip. You will have contraceptive protection with your first pill but you will not have a bleed until after you finish your first strip of this pill.
• If you are currently on a 28-day pill, start taking this pill the day after your last active pill. You will have contraceptive protection with your first pill.
• You will not have a bleed until after you finish your first strip of this pill.
• Or if you are taking a Progestogen-only Pill (POP), start. This pill on the first day of bleeding, even if you have already taken the POP for that day. You will have contraceptive cover straight away. If you don't usually have any bleeding while you are taking a Progestogen-only Pill, you can stop taking it any day and start this pill the next day. You will need to use extra contraception, such as a condom, for seven days.
• Changing to this pill from a Progestogen-only injection, implant of Progestogen releasing intrauterine device (IUD). Start taking this pill when your next injection is due or on the day that your implant or IUD is removed. Make sure you also use an additional contraceptive method, such as a condom, for the first 7 days that you are taking this pill.

Starting this pill after a miscarriage or abortion: If you have had a miscarriage or an abortion, your doctor may tell you to start taking this pill straight away. This means that you will have contraceptive protection with your first pill. Contraception after having a baby if you have just had a baby, ask your doctor for advice about contraception.

If you are not breast-feeding:

• You can start taking this pill three weeks after the birth or more than three weeks after the birth but you need to use extra contraception, such as a condom until you have taken the first seven pills correctly.
• If you have had sex since birth there is a chance that you could be pregnant, you should therefore use another form of contraception, such as a condom. In this case, take your first this pill on the first day of your next period.

A missed pill:

• If you have missed any of the pills in a strip and you do not bleed in the first pill-free break, you may be pregnant. Contact your doctor or family planning clinic or do a pregnancy test yourself.
• If you start a new strip of pills late or make your "week off" longer than seven days, you may not be protected from pregnancy.
• If you had sex in the last seven days, ask your doctor, family planning nurse or pharmacist for advice. You may need to consider emergency contraception. You should also use extra contraception, such as a condom, for seven days.

A lost pill: If you lose a pill, either take the last pill of the strip in place of the lost pill. Then take all the other pills on their proper days. Your cycle will be one day shorter than normal, but your contraceptive protection won't be affected. After your seven pill-free days you will have a new starting day, one day earlier than before.

If you are sick or have diarrhea: If you are sick (vomit) or have very bad diarrhoea your body may not get its usual dose of hormones from that pill. If you vomit within 3 to 4 hours after taking your pill, this is like missing a pill. You must follow the advice for missed pills. If you have severe diarrhoea for more than 12 hours after taking. This pill follow the instructions for if you are more than 12 hours late, A missed pill. Talk to your doctor if your stomach upset carries on or gets worse. He or she may recommend another form of contraception.

Missed a period- could you be pregnant: Occasionally, you may miss a withdrawal bleed. This could mean that you are pregnant, but that is very unlikely if you have taken your pills correctly. Start your next strip at the normal time. If you think that you might have put yourself at risk of pregnancy (for example, by missing pills or taking other medicines), or if you miss a second bleed, you should do a pregnancy test.

Taking more than one pill should not cause harm: It is unlikely that taking more than one pill will do you any harm, but you may feel sick, vomit or have some vaginal bleeding. Talk to your doctor if you have any of these symptoms.

You can delay a period: If you want to delay having a period, finish the strip of pills you are taking. Start the next strip the next day without a break. Take this strip the usual way. After the second strip, leave seven pill-free days as usual, then start your next strip of pills in the normal way. When you use the second strip, you may have some unexpected bleeding or spotting on the days that you take the pill, but don't worry.

When you want to get pregnant: If you are planning a baby, it’s best to use another method of contraception after stopping this pill until you have had a proper period. Your doctor or midwife relies on the date of your last natural period before you get pregnant to tell you when your baby is due. However, it will not cause you or the baby any harm if you get pregnant straight away.

You should not use this tablet if you have or ever had any of the conditions listed below:

• A blood clot in a blood vessel of legs (Deep Vein Thrombosis, DVT), lungs (Pulmonary Embolus, PE) or other organs
• A disorder affecting blood clotting- for instance, protein C deficiency, protein S deficiency, antithrombin-lll deficiency, Factor V Leiden or antiphospholipid antibodies
• Need an operation or off to feet for a long time
• A heart attack or stroke
• Angina pectoris
• Any of the following diseases that may increase risk of a clot in the arteries: Severe diabetes with blood vessel damage, Very high blood pressure, A very high level of fat in the blood (cholesterol or triglycerides), A condition known as hyperhomocysteinaemia
• A type of migraine called "migraine with aura"
• Severe liver disease or liver tumour
• Cancer affected by sex hormones- such as some cancers of the breast, womb lining or ovary
• Vaginal bleeding that has not been explained by doctor
• Allergy (hypersensitivity) to any of the ingredients in this tablet

If you suffer from any of these or get them for the first time while taking this tablet contact your doctor as soon as possible stop taking this tablet.

If you ever need to take another medicine at the same time as being on the pill, always tell your doctor, pharmacist or dentist that you're taking this tablet. Also check the leaflets that come with all your medicines to see if they can be taken with hormonal contraceptives.

Some medicines can stop this tablet from working properly-for example:

• Some medicines used to treat epilepsy (Primidone, Phenytoins, Barbiturates, Carbamazepine, Oxcarbazepine, Topiramate, Felbamate)
• Medicine to treat tuberculosis (Rifampicin)
• Certain HIV medicines (Ritonavir)
• Certain antibiotics (Penicillins, Tetracyclines)
• St. John’s Wort (a herbal remedy)
• Griseofulvin (an antifungal drug)

If you do need to take one of these medicines, this tablet may not be suitable for you or you may be able to take this tablet and use extra contraception for a while. This tablet can also affect how well other medicines work. For example, Cyclosporine and Lamotrigine.

Taking these medicines with food and drink: There are no special instructions about food and drink while on this tablet.

Bleeding between periods should not last long: A few women have a little unexpected bleeding or spotting while they are taking this pill, especially during the first few months. Normally, this bleeding is nothing to worry about and will stop after a day or two. Keep taking this pill as usual; the problem should disappear after the first few strips. You may also have unexpected bleeding if you are not taking your pills regularly, so try to take your pill at the same time every day. Also, unexpected bleeding can sometimes be caused by other medicines. Make an appointment to see your doctor if you get breakthrough bleeding or spotting that:

• Carries on for more than the first few months
• Starts after you’ve been taking this pill for a while
• Carries on even after you’ve stopped taking this pill

Do not use this tablet if you are pregnant. If you think you might be pregnant, do a pregnancy test to confirm that you are before you stop taking this tablet. This tablet is not recommended for use in breastfeeding. Ask your doctor or family planning nurse about alternative contraception.

Store in a cool & dry place, protect from light & moisture. Keep out of the reach of children.

Tamsulosin Hydrochloride is indicated for the treatment of functional symptoms of Benign Prostatic Hyperplasia (BPH).

BPH/ Urinary retention/ Urinary incontinence

Tamsulosin, a selective alpha1 adrenoceptor blocking agent, exhibits its selectivity for alpha1 A adrenoceptors in human prostate. Blockade of these adrenoceptors can cause smooth muscle in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and a reduction in symptoms of BPH. Absorption of Tamsulosin hydrochloride capsule 0.4mg is essentially complete (90%) following oral administration under fasting conditions. The time to maximum concentration (Tmax) is reached by four to five hours under fasting conditions and by six to seven hours when administered with food. Tamsulosin hydrochloride is extremely bound to human plasma protein (94% to 99%). Tamsulosin hydrochloride is extensively metabolized by cytochrome P 450 enzymes in the liver and less than 10% of the dose is excreted in urine as unchanged form. Following intravenous or oral administration of an immediate-release formulation the elimination half-life of Tamsulosin hydrochloride in plasma ranges from five to seven hours. Because of the absorption rate controlled pharmacokinetics with Prostam capsules, the apparent half-life of Tamsulosin hydrochloride is approximately 9 to 13 hours in healthy volunteers and 14 to 15 hours in the target population.

Tamsulosin Hydrochloride 0.4 mg (one capsule) daily, to be taken after meal at night. The dose may be increased after 2 to 4 weeks, if necessary, to Tamsulosin Hydrochloride 0.8 mg (two capsules) once daily. If Tamsulosin Hydrochloride administration is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should be started again with the Tamsulosin Hydrochloride 0.4 mg (one capsule) once daily dose. The capsule should be swallowed whole with a glass of water (about 150 ml) in the standing or sitting position. The capsule should not be crunched or chewed, as this will interfere with the modified release of the active ingredient.

The following adverse reactions have been reported during the use of Tamsulosin: dizziness, abnormal ejaculation and; less frequently headache, asthenia, postural hypotension and palpitations.

Tamsulosin hydrochloride is contraindicated in patients with hypersensitivity to it; history of orthostatic hypotension; severe hepatic insufficiency.

As with other alpha1 blockers, a reduction in blood pressure can occur in individual cases during treatment with Tamsulosin, as a result of which, rarely, syncope can occur, at the first signs of orthostatic hypotension (dizziness, weakness) the patient should sit or lie down until the symptoms have disappeared. And they should be cautioned to avoid situations where injury could result (like driving, operating machinery or performing hazardous tasks).

Before therapy with Tamsulosin is initiated the patient should be examined in order to exclude the presence of other conditions which can cause the same symptoms as Benign Prostatic hyperplasia. Digital rectal examination and when the necessary determination of Prostate Specific Antigen (PSA) should be performed before treatment and at regular intervals afterwards.

Rarely, transient postural symptoms have occurred during orthostatic provocation testing after the first dose. Use in patients with micturition syncope is not advised.

Effects on ability to drive and use machines: No data is available on whether Tamsulosin adversely affects the ability to drive or operate machines. However, in this respect, patients should be aware of the fact that dizziness can occur.

Concurrent administration of other alfa1-adrenoceptor antagonists could lead to hypotensive effects. No interactions have been seen when Tamsulosin was given concomitantly with either atenolol, enalapril or nifedipine. Concomitant cimetidine brings about a rise and frusemide a fall in plasma levels of Tamsulosin, but as levels remain within the normal range posology need not be changed. No interactions at the level of hepatic metabolism have been seen during in vitro studies with liver microsomal fractions (representative of the cytochrome P450-linked drug-metabolizing enzyme system), involving amitriptyline, salbutamol, glibenclamide, and finasteride. Diclofenac and warfarin, however, may increase the elimination rate of Tamsulosin.

Use of Tamsulosin in pregnancy and lactation is not recommended.

No case of acute overdosage has been reported. However, acute hypotension is likely to occur after overdosage in which case cardiovascular support should be given. Blood pressure can be restored and the 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.

Store in a cool and dry place, below 30°C, protected from light.

Lasmiditan is indicated for the acute treatment of migraine with or without aura in adults. Lasmiditan is not indicated for the preventive treatment of migraine.

Other drugs for migraine

The acute treatment of migraine headaches has, in the past, been achieved via constriction of cerebral blood vessels, as the acute dilation of these vessels observed during migraines was thought to be the cause of the associated pain. The neurogenic hypothesis of migraine pathophysiology, an alternative to the vascular hypothesis, suggests that cerebral vasodilation is a secondary mechanism in migraine pathogenesis, and that the main contributor to migraine headache pain is the increased pathogenic firing of trigeminal nerve pathways.

While the precise mechanism of action of lasmiditan is unclear, it likely supports this neurogenic hypothesis by exerting its therapeutic effects through potent and selective agonism of the 5-HT_1F receptor. 5-HT_1F receptors are found in both the central and peripheral nervous system (on the central and peripheral ends of trigeminal neurons) and appear to contribute to hyperpolarization of nerve terminals and inhibition of trigeminal neuronal activity. Lasmiditan's agonism at these receptors may, therefore, inhibit the firing of trigeminal nerves responsible for migraine headache pain.

Lasmiditan has virtually no affinity for other 5-HT receptor subtypes or monoamine receptors (e.g. adrenergic, dopaminergic).

The recommended dose of Lasmiditan is 50 mg, 100 mg, or 200 mg taken orally, as needed. No more than one dose should be taken in 24 hours, and Lasmiditan should not be taken unless the patient can wait at least 8 hours between dosing and driving or operating machinery. A second dose of Lasmiditan has not been shown to be effective for the same migraine attack. The safety of treating an average of more than 4 migraine attacks in a 30-day period has not been established. Lasmiditan may be taken with or without food.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Hepatic Impairment: No dosage adjustment is needed for patients with mild or moderate hepatic impairment (Child-Pugh A or B). In patients with severe hepatic impairment (Child-Pugh C) and its use in these patients is not recommended.

The most common side effects of Lasmiditan include: dizziness, sleepiness, numbness, feeling tired, tingling.

Driving Impairment: Advise patients not to drive or operate machinery until at least 8 hours after taking each dose of Lasmiditan. Patients who cannot follow this advice should not take Lasmiditan. Patients may not be able to assess their own driving competence and the degree of impairment caused by Lasmiditan.

Central Nervous System (CNS) Depression: Lasmiditan may cause CNS depression and should be used with caution if used in combination with alcohol or other CNS depressants.

Serotonin Syndrome: Reactions consistent with serotonin syndrome were reported in patients treated with Lasmiditan. Discontinue Lasmiditan if symptoms of serotonin syndrome occur.

Medication Overuse Headache: Detoxification may be necessary.

CNS Depressants: Concomitant administration of Lasmiditan and alcohol or other CNS depressant drugs has not been evaluated in clinical studies. Because of the potential of Lasmiditan to cause sedation, as well as other cognitive and/or neuropsychiatric adverse reactions, Lasmiditan should be used with caution if used in combination with alcohol or other CNS depressants

Serotonergic Drugs: Concomitant administration of Lasmiditan and drugs (e.g., SSRIs, SNRIs, TCAs, MAO inhibitors, trazodone, etc.), over-the-counter medications (e.g., dextromethorphan), or herbal supplements (e.g., St. John’s Wort) that increase serotonin may increase the risk of serotonin syndrome. Use Lasmiditan with caution in patients taking medications that increase serotonin.

Heart Rate Lowering Drugs: Lasmiditan has been associated with a lowering of heart rate. In a drug interaction study, addition of a single 200 mg dose of Lasmiditan to propranolol decreased heart rate by an additional 5 beats per minute compared to propranolol alone, for a mean maximum of 19 beats per minute. Use Lasmiditan with caution in patients taking concomitant medications that lower heart rate if this magnitude of heart rate decrease may pose a concern.

P-gp and Breast Cancer Resistant Protein (BCRP): Lasmiditan inhibits P-gp and BCRP in vitro. Concomitant use of Lasmiditan and drugs that are P-gp or BCRP substrates should be avoided.

There are no adequate data on the developmental risk associated with the use of Lasmiditan in pregnant women. There are no data on the presence of lasmiditan in human milk, the effects of lasmiditan on the breastfed infant, or the effects of lasmiditan on milk production. Excretion of lasmiditan and/or metabolites into milk, at levels times those in maternal plasma, was observed in lactating rats following oral administration of lasmiditan. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Lasmiditan and any potential adverse effects on the breastfed infant from Lasmiditan or from the underlying maternal condition.

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

Lasmiditan is indicated for the acute treatment of migraine with or without aura in adults. Lasmiditan is not indicated for the preventive treatment of migraine.

Other drugs for migraine

The acute treatment of migraine headaches has, in the past, been achieved via constriction of cerebral blood vessels, as the acute dilation of these vessels observed during migraines was thought to be the cause of the associated pain. The neurogenic hypothesis of migraine pathophysiology, an alternative to the vascular hypothesis, suggests that cerebral vasodilation is a secondary mechanism in migraine pathogenesis, and that the main contributor to migraine headache pain is the increased pathogenic firing of trigeminal nerve pathways.

While the precise mechanism of action of lasmiditan is unclear, it likely supports this neurogenic hypothesis by exerting its therapeutic effects through potent and selective agonism of the 5-HT_1F receptor. 5-HT_1F receptors are found in both the central and peripheral nervous system (on the central and peripheral ends of trigeminal neurons) and appear to contribute to hyperpolarization of nerve terminals and inhibition of trigeminal neuronal activity. Lasmiditan's agonism at these receptors may, therefore, inhibit the firing of trigeminal nerves responsible for migraine headache pain.

Lasmiditan has virtually no affinity for other 5-HT receptor subtypes or monoamine receptors (e.g. adrenergic, dopaminergic).

The recommended dose of Lasmiditan is 50 mg, 100 mg, or 200 mg taken orally, as needed. No more than one dose should be taken in 24 hours, and Lasmiditan should not be taken unless the patient can wait at least 8 hours between dosing and driving or operating machinery. A second dose of Lasmiditan has not been shown to be effective for the same migraine attack. The safety of treating an average of more than 4 migraine attacks in a 30-day period has not been established. Lasmiditan may be taken with or without food.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Hepatic Impairment: No dosage adjustment is needed for patients with mild or moderate hepatic impairment (Child-Pugh A or B). In patients with severe hepatic impairment (Child-Pugh C) and its use in these patients is not recommended.

The most common side effects of Lasmiditan include: dizziness, sleepiness, numbness, feeling tired, tingling.

Driving Impairment: Advise patients not to drive or operate machinery until at least 8 hours after taking each dose of Lasmiditan. Patients who cannot follow this advice should not take Lasmiditan. Patients may not be able to assess their own driving competence and the degree of impairment caused by Lasmiditan.

Central Nervous System (CNS) Depression: Lasmiditan may cause CNS depression and should be used with caution if used in combination with alcohol or other CNS depressants.

Serotonin Syndrome: Reactions consistent with serotonin syndrome were reported in patients treated with Lasmiditan. Discontinue Lasmiditan if symptoms of serotonin syndrome occur.

Medication Overuse Headache: Detoxification may be necessary.

CNS Depressants: Concomitant administration of Lasmiditan and alcohol or other CNS depressant drugs has not been evaluated in clinical studies. Because of the potential of Lasmiditan to cause sedation, as well as other cognitive and/or neuropsychiatric adverse reactions, Lasmiditan should be used with caution if used in combination with alcohol or other CNS depressants

Serotonergic Drugs: Concomitant administration of Lasmiditan and drugs (e.g., SSRIs, SNRIs, TCAs, MAO inhibitors, trazodone, etc.), over-the-counter medications (e.g., dextromethorphan), or herbal supplements (e.g., St. John’s Wort) that increase serotonin may increase the risk of serotonin syndrome. Use Lasmiditan with caution in patients taking medications that increase serotonin.

Heart Rate Lowering Drugs: Lasmiditan has been associated with a lowering of heart rate. In a drug interaction study, addition of a single 200 mg dose of Lasmiditan to propranolol decreased heart rate by an additional 5 beats per minute compared to propranolol alone, for a mean maximum of 19 beats per minute. Use Lasmiditan with caution in patients taking concomitant medications that lower heart rate if this magnitude of heart rate decrease may pose a concern.

P-gp and Breast Cancer Resistant Protein (BCRP): Lasmiditan inhibits P-gp and BCRP in vitro. Concomitant use of Lasmiditan and drugs that are P-gp or BCRP substrates should be avoided.

There are no adequate data on the developmental risk associated with the use of Lasmiditan in pregnant women. There are no data on the presence of lasmiditan in human milk, the effects of lasmiditan on the breastfed infant, or the effects of lasmiditan on milk production. Excretion of lasmiditan and/or metabolites into milk, at levels times those in maternal plasma, was observed in lactating rats following oral administration of lasmiditan. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Lasmiditan and any potential adverse effects on the breastfed infant from Lasmiditan or from the underlying maternal condition.

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

Midazolam is indicated in-

• Short-term treatment of insomnia.
• Sedation in premedication before surgical or diagnostic procedures.

Benzodiazepine hypnotics, Benzodiazepine sedatives

The actions of benzodiazepines such as midazolam are mediated through the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), which is one of the major inhibitory neurotransmitters in the central nervous system. Benzodiazepines increase the activity of GABA, thereby producing a sedating effect, relaxing skeletal muscles, and inducing sleep, anesthesia, and amnesia. Benzodiazepines bind to the benzodiazepine site on GABA-A receptors, which potentiates the effects of GABA by increasing the frequency of chloride channel opening. These receptors have been identified in different body tissues including the heart and skeletal muscle, although mainly appear to be present in the central nervous system.

Oral dosage:

• For adults: 7.5-15 mg daily.
• In elderly and debilitated patients: The recommended dose is 7.5 mg.
• In premedication: 15 mg of Midazolam should be given 30-60 minutes before the procedure.

Intravenous administration:

• Endoscopic or Cardiovascular Procedures: In healthy adults, the initial dose is approximately 2.5 mg. In cases of severe illness and in elderly patients, the initial dose must be reduced to 1 to 1.5 mg.
• Induction of Anesthesia: The dose is 10-15 mg.

Intramuscular administration:

• Adult: 0.07-0.1 mg/kg body weight. The usual dose is about 5 mg.
• Children: 0.15-0.20 mg/kg
• Elderly and debilitated patients: 0.025-0.05 mg/kg

Rectal administration in children:

• For preoperative sedation: Rectal administration of the ampoule solution (0.35-0.45 mg/kg) 20-30 min. before induction of general anesthesia.

At the start of therapy, drowsiness during daytime, confusion, fatigue, headache and muscle weakness may occur which usually disappear with repeated administration. Following parenteral (IV or IM) administration of Midazolam, fluctuations in vital signs have been noted including respiratory depression, apnea, variations in blood pressure and pulse rate.

Midazolam must not be given to patients with severe respiratory insufficiency, severe hepatic insufficiency, myasthenia gravis, sleep apnea syndrome and with known hypersensitivity to benzodiazepines or to any component of the product

Midazolam IV should be administered very slowly.

Midazolam can enhance the central sedative effect of neuroleptics, tranquillizers, antidepressants, sleep-inducing drugs, analgesics, anaesthetics, antipsychotics, anxiolytics, antiepileptic drugs and sedative antihistamines.

Midazolam should be avoided during pregnancy unless there is no safer alternative. Since Midazolam passes into breast milk, it should not be administered to breast-feeding mothers.

Extreme overdosage may lead to coma, areflexia, cardiorespiratory depression and apnea. The effects of overdosage can be controlled with benzodiazepine antagonist flumazenil.

Protect from light and moisture, store in cool and dry place. Keep out of the reach of children.

Midazolam is indicated in-

• Short-term treatment of insomnia.
• Sedation in premedication before surgical or diagnostic procedures.

Benzodiazepine hypnotics, Benzodiazepine sedatives

The actions of benzodiazepines such as midazolam are mediated through the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), which is one of the major inhibitory neurotransmitters in the central nervous system. Benzodiazepines increase the activity of GABA, thereby producing a sedating effect, relaxing skeletal muscles, and inducing sleep, anesthesia, and amnesia. Benzodiazepines bind to the benzodiazepine site on GABA-A receptors, which potentiates the effects of GABA by increasing the frequency of chloride channel opening. These receptors have been identified in different body tissues including the heart and skeletal muscle, although mainly appear to be present in the central nervous system.

Oral dosage:

• For adults: 7.5-15 mg daily.
• In elderly and debilitated patients: The recommended dose is 7.5 mg.
• In premedication: 15 mg of Midazolam should be given 30-60 minutes before the procedure.

Intravenous administration:

• Endoscopic or Cardiovascular Procedures: In healthy adults, the initial dose is approximately 2.5 mg. In cases of severe illness and in elderly patients, the initial dose must be reduced to 1 to 1.5 mg.
• Induction of Anesthesia: The dose is 10-15 mg.

Intramuscular administration:

• Adult: 0.07-0.1 mg/kg body weight. The usual dose is about 5 mg.
• Children: 0.15-0.20 mg/kg
• Elderly and debilitated patients: 0.025-0.05 mg/kg

Rectal administration in children:

• For preoperative sedation: Rectal administration of the ampoule solution (0.35-0.45 mg/kg) 20-30 min. before induction of general anesthesia.

At the start of therapy, drowsiness during daytime, confusion, fatigue, headache and muscle weakness may occur which usually disappear with repeated administration. Following parenteral (IV or IM) administration of Midazolam, fluctuations in vital signs have been noted including respiratory depression, apnea, variations in blood pressure and pulse rate.

Midazolam must not be given to patients with severe respiratory insufficiency, severe hepatic insufficiency, myasthenia gravis, sleep apnea syndrome and with known hypersensitivity to benzodiazepines or to any component of the product

Midazolam IV should be administered very slowly.

Midazolam can enhance the central sedative effect of neuroleptics, tranquillizers, antidepressants, sleep-inducing drugs, analgesics, anaesthetics, antipsychotics, anxiolytics, antiepileptic drugs and sedative antihistamines.

Midazolam should be avoided during pregnancy unless there is no safer alternative. Since Midazolam passes into breast milk, it should not be administered to breast-feeding mothers.

Extreme overdosage may lead to coma, areflexia, cardiorespiratory depression and apnea. The effects of overdosage can be controlled with benzodiazepine antagonist flumazenil.

Protect from light and moisture, store in cool and dry place. Keep out of the reach of children.

Midazolam is indicated in-

• Short-term treatment of insomnia.
• Sedation in premedication before surgical or diagnostic procedures.

Benzodiazepine hypnotics, Benzodiazepine sedatives

The actions of benzodiazepines such as midazolam are mediated through the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), which is one of the major inhibitory neurotransmitters in the central nervous system. Benzodiazepines increase the activity of GABA, thereby producing a sedating effect, relaxing skeletal muscles, and inducing sleep, anesthesia, and amnesia. Benzodiazepines bind to the benzodiazepine site on GABA-A receptors, which potentiates the effects of GABA by increasing the frequency of chloride channel opening. These receptors have been identified in different body tissues including the heart and skeletal muscle, although mainly appear to be present in the central nervous system.

Oral dosage:

• For adults: 7.5-15 mg daily.
• In elderly and debilitated patients: The recommended dose is 7.5 mg.
• In premedication: 15 mg of Midazolam should be given 30-60 minutes before the procedure.

Intravenous administration:

• Endoscopic or Cardiovascular Procedures: In healthy adults, the initial dose is approximately 2.5 mg. In cases of severe illness and in elderly patients, the initial dose must be reduced to 1 to 1.5 mg.
• Induction of Anesthesia: The dose is 10-15 mg.

Intramuscular administration:

• Adult: 0.07-0.1 mg/kg body weight. The usual dose is about 5 mg.
• Children: 0.15-0.20 mg/kg
• Elderly and debilitated patients: 0.025-0.05 mg/kg

Rectal administration in children:

• For preoperative sedation: Rectal administration of the ampoule solution (0.35-0.45 mg/kg) 20-30 min. before induction of general anesthesia.

At the start of therapy, drowsiness during daytime, confusion, fatigue, headache and muscle weakness may occur which usually disappear with repeated administration. Following parenteral (IV or IM) administration of Midazolam, fluctuations in vital signs have been noted including respiratory depression, apnea, variations in blood pressure and pulse rate.

Midazolam must not be given to patients with severe respiratory insufficiency, severe hepatic insufficiency, myasthenia gravis, sleep apnea syndrome and with known hypersensitivity to benzodiazepines or to any component of the product

Midazolam IV should be administered very slowly.

Midazolam can enhance the central sedative effect of neuroleptics, tranquillizers, antidepressants, sleep-inducing drugs, analgesics, anaesthetics, antipsychotics, anxiolytics, antiepileptic drugs and sedative antihistamines.

Midazolam should be avoided during pregnancy unless there is no safer alternative. Since Midazolam passes into breast milk, it should not be administered to breast-feeding mothers.

Extreme overdosage may lead to coma, areflexia, cardiorespiratory depression and apnea. The effects of overdosage can be controlled with benzodiazepine antagonist flumazenil.

Protect from light and moisture, store in cool and dry place. Keep out of the reach of children.

Midazolam is indicated in-

• Short-term treatment of insomnia.
• Sedation in premedication before surgical or diagnostic procedures.

Benzodiazepine hypnotics, Benzodiazepine sedatives

The actions of benzodiazepines such as midazolam are mediated through the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), which is one of the major inhibitory neurotransmitters in the central nervous system. Benzodiazepines increase the activity of GABA, thereby producing a sedating effect, relaxing skeletal muscles, and inducing sleep, anesthesia, and amnesia. Benzodiazepines bind to the benzodiazepine site on GABA-A receptors, which potentiates the effects of GABA by increasing the frequency of chloride channel opening. These receptors have been identified in different body tissues including the heart and skeletal muscle, although mainly appear to be present in the central nervous system.

Oral dosage:

• For adults: 7.5-15 mg daily.
• In elderly and debilitated patients: The recommended dose is 7.5 mg.
• In premedication: 15 mg of Midazolam should be given 30-60 minutes before the procedure.

Intravenous administration:

• Endoscopic or Cardiovascular Procedures: In healthy adults, the initial dose is approximately 2.5 mg. In cases of severe illness and in elderly patients, the initial dose must be reduced to 1 to 1.5 mg.
• Induction of Anesthesia: The dose is 10-15 mg.

Intramuscular administration:

• Adult: 0.07-0.1 mg/kg body weight. The usual dose is about 5 mg.
• Children: 0.15-0.20 mg/kg
• Elderly and debilitated patients: 0.025-0.05 mg/kg

Rectal administration in children:

• For preoperative sedation: Rectal administration of the ampoule solution (0.35-0.45 mg/kg) 20-30 min. before induction of general anesthesia.

At the start of therapy, drowsiness during daytime, confusion, fatigue, headache and muscle weakness may occur which usually disappear with repeated administration. Following parenteral (IV or IM) administration of Midazolam, fluctuations in vital signs have been noted including respiratory depression, apnea, variations in blood pressure and pulse rate.

Midazolam must not be given to patients with severe respiratory insufficiency, severe hepatic insufficiency, myasthenia gravis, sleep apnea syndrome and with known hypersensitivity to benzodiazepines or to any component of the product

Midazolam IV should be administered very slowly.

Midazolam can enhance the central sedative effect of neuroleptics, tranquillizers, antidepressants, sleep-inducing drugs, analgesics, anaesthetics, antipsychotics, anxiolytics, antiepileptic drugs and sedative antihistamines.

Midazolam should be avoided during pregnancy unless there is no safer alternative. Since Midazolam passes into breast milk, it should not be administered to breast-feeding mothers.

Extreme overdosage may lead to coma, areflexia, cardiorespiratory depression and apnea. The effects of overdosage can be controlled with benzodiazepine antagonist flumazenil.

Protect from light and moisture, store in cool and dry place. Keep out of the reach of children.

Midazolam is indicated in-

• Short-term treatment of insomnia.
• Sedation in premedication before surgical or diagnostic procedures.

Benzodiazepine hypnotics, Benzodiazepine sedatives

The actions of benzodiazepines such as midazolam are mediated through the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), which is one of the major inhibitory neurotransmitters in the central nervous system. Benzodiazepines increase the activity of GABA, thereby producing a sedating effect, relaxing skeletal muscles, and inducing sleep, anesthesia, and amnesia. Benzodiazepines bind to the benzodiazepine site on GABA-A receptors, which potentiates the effects of GABA by increasing the frequency of chloride channel opening. These receptors have been identified in different body tissues including the heart and skeletal muscle, although mainly appear to be present in the central nervous system.

Oral dosage:

• For adults: 7.5-15 mg daily.
• In elderly and debilitated patients: The recommended dose is 7.5 mg.
• In premedication: 15 mg of Midazolam should be given 30-60 minutes before the procedure.

Intravenous administration:

• Endoscopic or Cardiovascular Procedures: In healthy adults, the initial dose is approximately 2.5 mg. In cases of severe illness and in elderly patients, the initial dose must be reduced to 1 to 1.5 mg.
• Induction of Anesthesia: The dose is 10-15 mg.

Intramuscular administration:

• Adult: 0.07-0.1 mg/kg body weight. The usual dose is about 5 mg.
• Children: 0.15-0.20 mg/kg
• Elderly and debilitated patients: 0.025-0.05 mg/kg

Rectal administration in children:

• For preoperative sedation: Rectal administration of the ampoule solution (0.35-0.45 mg/kg) 20-30 min. before induction of general anesthesia.

At the start of therapy, drowsiness during daytime, confusion, fatigue, headache and muscle weakness may occur which usually disappear with repeated administration. Following parenteral (IV or IM) administration of Midazolam, fluctuations in vital signs have been noted including respiratory depression, apnea, variations in blood pressure and pulse rate.

Midazolam must not be given to patients with severe respiratory insufficiency, severe hepatic insufficiency, myasthenia gravis, sleep apnea syndrome and with known hypersensitivity to benzodiazepines or to any component of the product

Midazolam IV should be administered very slowly.

Midazolam can enhance the central sedative effect of neuroleptics, tranquillizers, antidepressants, sleep-inducing drugs, analgesics, anaesthetics, antipsychotics, anxiolytics, antiepileptic drugs and sedative antihistamines.

Midazolam should be avoided during pregnancy unless there is no safer alternative. Since Midazolam passes into breast milk, it should not be administered to breast-feeding mothers.

Extreme overdosage may lead to coma, areflexia, cardiorespiratory depression and apnea. The effects of overdosage can be controlled with benzodiazepine antagonist flumazenil.

Protect from light and moisture, store in cool and dry place. Keep out of the reach of children.

Midazolam is indicated in-

• Short-term treatment of insomnia.
• Sedation in premedication before surgical or diagnostic procedures.

Benzodiazepine hypnotics, Benzodiazepine sedatives

The actions of benzodiazepines such as midazolam are mediated through the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), which is one of the major inhibitory neurotransmitters in the central nervous system. Benzodiazepines increase the activity of GABA, thereby producing a sedating effect, relaxing skeletal muscles, and inducing sleep, anesthesia, and amnesia. Benzodiazepines bind to the benzodiazepine site on GABA-A receptors, which potentiates the effects of GABA by increasing the frequency of chloride channel opening. These receptors have been identified in different body tissues including the heart and skeletal muscle, although mainly appear to be present in the central nervous system.

Oral dosage:

• For adults: 7.5-15 mg daily.
• In elderly and debilitated patients: The recommended dose is 7.5 mg.
• In premedication: 15 mg of Midazolam should be given 30-60 minutes before the procedure.

Intravenous administration:

• Endoscopic or Cardiovascular Procedures: In healthy adults, the initial dose is approximately 2.5 mg. In cases of severe illness and in elderly patients, the initial dose must be reduced to 1 to 1.5 mg.
• Induction of Anesthesia: The dose is 10-15 mg.

Intramuscular administration:

• Adult: 0.07-0.1 mg/kg body weight. The usual dose is about 5 mg.
• Children: 0.15-0.20 mg/kg
• Elderly and debilitated patients: 0.025-0.05 mg/kg

Rectal administration in children:

• For preoperative sedation: Rectal administration of the ampoule solution (0.35-0.45 mg/kg) 20-30 min. before induction of general anesthesia.

At the start of therapy, drowsiness during daytime, confusion, fatigue, headache and muscle weakness may occur which usually disappear with repeated administration. Following parenteral (IV or IM) administration of Midazolam, fluctuations in vital signs have been noted including respiratory depression, apnea, variations in blood pressure and pulse rate.

Midazolam must not be given to patients with severe respiratory insufficiency, severe hepatic insufficiency, myasthenia gravis, sleep apnea syndrome and with known hypersensitivity to benzodiazepines or to any component of the product

Midazolam IV should be administered very slowly.

Midazolam can enhance the central sedative effect of neuroleptics, tranquillizers, antidepressants, sleep-inducing drugs, analgesics, anaesthetics, antipsychotics, anxiolytics, antiepileptic drugs and sedative antihistamines.

Midazolam should be avoided during pregnancy unless there is no safer alternative. Since Midazolam passes into breast milk, it should not be administered to breast-feeding mothers.

Extreme overdosage may lead to coma, areflexia, cardiorespiratory depression and apnea. The effects of overdosage can be controlled with benzodiazepine antagonist flumazenil.

Protect from light and moisture, store in cool and dry place. Keep out of the reach of children.

This is indicated for cataract surgery to obtain mydriasis (dilation of the pupil) and intraocular anesthesia during the surgical procedure.

Other ophthalmic preparations

Used only in the elderly and adults undergoing cataract surgery. The injection has to be administered by an ophthalmic surgeon, under local anesthesia, at the beginning of cataract surgery. The recommended dose is 0.2 ml of solution, in only one injection. The following procedure should be followed:

• Five minutes before performing the preoperative antiseptic procedure and the first incision, one to two drops of anesthetic eye drops should be instilled in the eye.
• At the beginning of surgery, 0.2 ml of the drop is slowly injected in only one injection via intracameral route, through the side port or principal port.

Most serious well-known complications occurring during or after cataract surgery:
Uncommon: may affect up to 1 in 100 people

• Injury to the lens (posterior capsule rupture)
• Swelling of the retina (cystoid macular edema)

Please seek urgent medical advice in this case.
Other side effects:
Uncommon: may affect up to 1 in 100 people

• Nervous system disorder: Headache
• Eye Disorder: Swelling of the cornea (keratitis), increased pressure in the eye, redness of the eye (ocular hyperaemia)
• Vascular disorder: High blood pressure (hypertension)

Do not use if the blister is damaged or broken. Open under aseptic conditions only. The product should be used immediately after opening of the ampoule and not be reused for the other eye or any other patient. This is not recommended:

• In combined cataract surgery with a certain type of eye surgery (vitrectomy)
• If the ocular anterior chamber is shallow
• If the patient has a history of acute narrow angle glaucoma

The doctor should consider the patient’s medical condition if he is suffering from hypertension, atherosclerosis or any kind of heart disease, hyperthyroidism, prostate gland disorders, epilepsy, any liver disease or kidney problem, breathing problem or myasthenia gravis.

This medicine should not be used during pregnancy and lactation.

Do not store above 30⁰C. Does not require refrigeration. Keep away from light and out of the reach of children. For single eye use only. This medicine should be used immediately after first opening of the ampoule. After use, discard the remaining solution appropriately. Do not keep it for subsequent use.

Anti-Leprotic drugs, Immunosuppressant

Thalidomide is a synthetic glutamic acid derivative immunomodulator with anti-inflammatory, antiangiogenetic, sedative and hypnotic activity.

In patients with erythema nodosum leprosum (ENL) the mechanism of action is not fully understood. Available data from in vitro studies and preliminary clinical trials suggest that the immunologic effects of this compound can vary substantially under different conditions, but may be related to suppression of excessive tumor necrosis factor-alpha (TNF-a) production and down-modulation of selected cell surface adhesion molecules involved in leukocyte migration. For example, administration of thalidomide has been reported to decrease circulating levels of TNF-a in patients with ENL, however, it has also been shown to increase plasma TNF-a levels in HIV-seropositive patients. As a cancer treatment, the drug may act as a VEGF inhibitor.

Multiple Myeloma: Thalidomide is administered in combination with dexamethasone in 28-day treatment cycles. The dose of Thalidomide is 200 mg administered orally once daily with water, preferably at bedtime and at least 1 hour after the evening meal. The dose of dexamethasone is 40 mg daily administered orally on days 1-4, 9-12, and 17-20 every 28 days.

Patients who develop adverse reactions such as constipation, somnolence, or peripheral neuropathy may benefit by either temporarily discontinuing the drug or continuing at a lower dose. With the abatement of these adverse reactions, the drug may be started at a lower dose or at the previous dose based on clinical judgment.

Erythema Nodosum Leprosum: For an episode of cutaneous ENL, Thalidomide dosing should be initiated at 100 to 300 mg/day, administered once daily with water, preferably at bedtime and at least 1 hour after the evening meal. Patients weighing less than 50 kilograms should be started at the low end of the dose range.

In patients with a severe cutaneous ENL reaction, or in those who have previously required higher doses to control the reaction, Thalidomide dosing may be initiated at higher doses up to 400 mg/day once daily at bedtime or in divided doses with water, at least 1 hour after meals.

In patients with moderate to severe neuritis associated with a severe ENL reaction, corticosteroids may be started concomitantly with Thalidomide. Steroid usage can be tapered and discontinued when the neuritis has ameliorated.

Dosing with Thalidomide should usually continue until signs and symptoms of active reaction have subsided, usually a period of at least 2 weeks. Patients may then be tapered off medication in 50 mg decrements every 2 to 4 weeks.

Patients who have a documented history of requiring prolonged maintenance treatment to prevent the recurrence of cutaneous ENL or who flare during tapering should be maintained on the minimum dose necessary to control the reaction. Tapering off medication should be attempted every 3 to 6 months, in decrements of 50 mg every 2 to 4 weeks.

Severe and irreversible peripheral neuropathy, constipation, dizziness, orthostatic hypotension, drowsiness, somnolence, bradycardia, increase of viral load in HIV-infected patients, hypersensitivity reaction.

Pregnancy and lactation.

All females of childbearing potential must use 2 reliable forms of contraception simultaneously 4 wk before starting therapy, during and 4 wk after therapy is discontinued. Therapy to be stopped immediately if pregnancy occurs. Male: Use of barrier methods of contraception if partner is of child-bearing potential. Do not donate blood or sperm during therapy. Patient should not drive or operate machinery. Discontinue therapy if any skin rash develops. Do not resume therapy if the rash is exfoliative, purpuric, or bullous, or if Stevens-Johnson syndrome or toxic epidermal necrolysis suspected

Thalidomide enhances sedative activity of barbiturates, alcohol, chlorpromazine and reserpine. Avoid use of other drugs that have the potential to cause peripheral neuropathy. Increased risk of thromboembolic events with darbepoetin-alfa and doxorubicin.

Pregnancy Category X. Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

Midazolam is indicated in-

• Short-term treatment of insomnia.
• Sedation in premedication before surgical or diagnostic procedures.

Benzodiazepine hypnotics, Benzodiazepine sedatives

The actions of benzodiazepines such as midazolam are mediated through the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), which is one of the major inhibitory neurotransmitters in the central nervous system. Benzodiazepines increase the activity of GABA, thereby producing a sedating effect, relaxing skeletal muscles, and inducing sleep, anesthesia, and amnesia. Benzodiazepines bind to the benzodiazepine site on GABA-A receptors, which potentiates the effects of GABA by increasing the frequency of chloride channel opening. These receptors have been identified in different body tissues including the heart and skeletal muscle, although mainly appear to be present in the central nervous system.

Oral dosage:

• For adults: 7.5-15 mg daily.
• In elderly and debilitated patients: The recommended dose is 7.5 mg.
• In premedication: 15 mg of Midazolam should be given 30-60 minutes before the procedure.

Intravenous administration:

• Endoscopic or Cardiovascular Procedures: In healthy adults, the initial dose is approximately 2.5 mg. In cases of severe illness and in elderly patients, the initial dose must be reduced to 1 to 1.5 mg.
• Induction of Anesthesia: The dose is 10-15 mg.

Intramuscular administration:

• Adult: 0.07-0.1 mg/kg body weight. The usual dose is about 5 mg.
• Children: 0.15-0.20 mg/kg
• Elderly and debilitated patients: 0.025-0.05 mg/kg

Rectal administration in children:

• For preoperative sedation: Rectal administration of the ampoule solution (0.35-0.45 mg/kg) 20-30 min. before induction of general anesthesia.

At the start of therapy, drowsiness during daytime, confusion, fatigue, headache and muscle weakness may occur which usually disappear with repeated administration. Following parenteral (IV or IM) administration of Midazolam, fluctuations in vital signs have been noted including respiratory depression, apnea, variations in blood pressure and pulse rate.

Midazolam must not be given to patients with severe respiratory insufficiency, severe hepatic insufficiency, myasthenia gravis, sleep apnea syndrome and with known hypersensitivity to benzodiazepines or to any component of the product

Midazolam IV should be administered very slowly.

Midazolam can enhance the central sedative effect of neuroleptics, tranquillizers, antidepressants, sleep-inducing drugs, analgesics, anaesthetics, antipsychotics, anxiolytics, antiepileptic drugs and sedative antihistamines.

Midazolam should be avoided during pregnancy unless there is no safer alternative. Since Midazolam passes into breast milk, it should not be administered to breast-feeding mothers.

Extreme overdosage may lead to coma, areflexia, cardiorespiratory depression and apnea. The effects of overdosage can be controlled with benzodiazepine antagonist flumazenil.

Protect from light and moisture, store in cool and dry place. Keep out of the reach of children.

Midazolam is indicated in-

• Short-term treatment of insomnia.
• Sedation in premedication before surgical or diagnostic procedures.

Benzodiazepine hypnotics, Benzodiazepine sedatives

The actions of benzodiazepines such as midazolam are mediated through the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), which is one of the major inhibitory neurotransmitters in the central nervous system. Benzodiazepines increase the activity of GABA, thereby producing a sedating effect, relaxing skeletal muscles, and inducing sleep, anesthesia, and amnesia. Benzodiazepines bind to the benzodiazepine site on GABA-A receptors, which potentiates the effects of GABA by increasing the frequency of chloride channel opening. These receptors have been identified in different body tissues including the heart and skeletal muscle, although mainly appear to be present in the central nervous system.

Oral dosage:

• For adults: 7.5-15 mg daily.
• In elderly and debilitated patients: The recommended dose is 7.5 mg.
• In premedication: 15 mg of Midazolam should be given 30-60 minutes before the procedure.

Intravenous administration:

• Endoscopic or Cardiovascular Procedures: In healthy adults, the initial dose is approximately 2.5 mg. In cases of severe illness and in elderly patients, the initial dose must be reduced to 1 to 1.5 mg.
• Induction of Anesthesia: The dose is 10-15 mg.

Intramuscular administration:

• Adult: 0.07-0.1 mg/kg body weight. The usual dose is about 5 mg.
• Children: 0.15-0.20 mg/kg
• Elderly and debilitated patients: 0.025-0.05 mg/kg

Rectal administration in children:

• For preoperative sedation: Rectal administration of the ampoule solution (0.35-0.45 mg/kg) 20-30 min. before induction of general anesthesia.

At the start of therapy, drowsiness during daytime, confusion, fatigue, headache and muscle weakness may occur which usually disappear with repeated administration. Following parenteral (IV or IM) administration of Midazolam, fluctuations in vital signs have been noted including respiratory depression, apnea, variations in blood pressure and pulse rate.

Midazolam must not be given to patients with severe respiratory insufficiency, severe hepatic insufficiency, myasthenia gravis, sleep apnea syndrome and with known hypersensitivity to benzodiazepines or to any component of the product

Midazolam IV should be administered very slowly.

Midazolam can enhance the central sedative effect of neuroleptics, tranquillizers, antidepressants, sleep-inducing drugs, analgesics, anaesthetics, antipsychotics, anxiolytics, antiepileptic drugs and sedative antihistamines.

Midazolam should be avoided during pregnancy unless there is no safer alternative. Since Midazolam passes into breast milk, it should not be administered to breast-feeding mothers.

Extreme overdosage may lead to coma, areflexia, cardiorespiratory depression and apnea. The effects of overdosage can be controlled with benzodiazepine antagonist flumazenil.

Protect from light and moisture, store in cool and dry place. Keep out of the reach of children.