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Azithromycin is acid-stable and can therefore be taken orally with no need of protection from gastric acids. It is readily absorbed; its absorption is greater on an empty stomach. Time to peak concentration in adults is 2.1 to 3.2 hours for oral dosage forms. Due to the high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations of azithromycin are released. The concentration of azithromycin in the tissues can be over 50 times higher than in plasma. This is due to ion trapping and the high lipid solubility.

Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.

Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:

• Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
• Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
• Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis , Mycoplasma pneumoniae , Betalactamase production should have no effect on azithromycin activity.
• Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C,F,G), Viridans group streptococci
• Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila
• Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia

Oral-
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.

Children:

• 10 mg/kg body weight once daily for 3 days for child over 6 months
• 200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
• 300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg.
• In typhoid fever, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given.

Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:

• 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
• The recommended dose of Azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
• Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.

Reconstitution procedure of suspension-

• Step 01: Shake the bottle well to loosen the powder.
• Step 02: Add boiled and cooled water up to the water mark of the bottle label.
• Step 03: Shake until powder is completely mixed with water.

Azithromycin should be taken at least 1 hour before or 2 hours after meal.

Azithromycin is well tolerated with a low incidence of side effects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhoea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy.

Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.

As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended. No dose adjustment is needed in patients with renal impairment.

Azithromycin absorption is reduced in presence of food and antacid. In patients receiving ergot alkaloids Azithromycin should be avoided because of the possibility of ergotism resulting from interaction of Azithromycin with the cytochrome P-450 system. As macrolides increase the plasma concentration of digoxin and cyclosporin, caution should be exercised while co-administration. There have been no drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone or Cimetidine.

Pregnancy Category of Azithromycin is B. Animal reproduction studies have demonstrated that Azithromycin has no evidence of harm to the fetus. There are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if adequate alternatives are not available. It is not known whether Azithromycin is secreted in breast milk. So, caution should be exercised when Azithromycin is administered to nursing women.

There is no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.

Keep in a dry place away from light and heat. Keep out of the reach of children.

This is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

Anti-emetic drugs

Doxylamine Succinate is an antihistamine that blocks Histamine (H1) receptor. It can cross the blood brain barrier and has a high affinity for H1 receptors in the brain that blocks H1 receptors. It also decreases the action of histamine at the H1 receptor by inhibiting both vestibular system & Muscarinic receptor. It affects the vestibular system & decreases the stimulation of the vomiting center. Its muscarinic receptor inhibition may also play a role in antihistamine antiemetic activity. Pyridoxine Hydrochloride is a vitamin B6 analog. It is used to prevent nausea and vomiting due to its antiemetic properties.

Initially, take one tablet orally at bedtime (Day 1). If this dose adequately controls symptoms the next day, continue taking one tablet daily at bedtime only. However, if symptoms persist on Day 2, increase the daily dose to one tablet in the morning and one tablet at bedtime. The maximum recommended dose is two tablets per day, one in the morning and one at bedtime. Take on an empty stomach with a glass of water. Swallow tablets whole. Do not crush, chew, or split this tablets. Take daily and not on an as needed basis.

Somnolence or other accidents resulting from the effect of the combined use of Doxylamine Succinate & Pyridoxine Hydrochloride with CNS depressants.

Doxylamine Succinate & Pyridoxine Hydrochloride is contraindicated in women with any of the following conditions:

• Known hypersensitivity to Doxylamine Succinate, other ethanolamine derivative antihistamines, Pyridoxine Hydrochloride or any inactive ingredient in the formulation
• Monoamine oxidase (MAO) inhibitors intensify and prolong the adverse central nervous system effects of Doxylamine Succinate & Pyridoxine Hydrochloride

Doxylamine Succinate & Pyridoxine Hydrochloride may cause somnolence due to the anticholinergic properties of Doxylamine Succinate, an antihistamine. Women should avoid engaging in activities, such as driving or operating heavy machinery, while using Doxylamine Succinate & Pyridoxine Hydrochloride. Doxylamine Succinate & Pyridoxine Hydrochloride use is not recommended if a woman is concurrently using central nervous system (CNS) depressants including alcohol.

Doxylamine Succinate & Pyridoxine Hydrochloride has anticholinergic properties and, therefore, should be used with caution in women with asthma, increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction or urinary bladder-neck obstruction.

Use of Doxylamine Succinate & Pyridoxine Hydrochloride is contraindicated in women who are taking monoamine oxidase inhibitors (MAOIs), which prolong and intensify the adverse central nervous system effects (the anticholinergic effects) of antihistamines. Concurrent use of alcohol and other CNS depressants (such as hypnotic sedatives and tranquilizers) with Doxylamine Succinate & Pyridoxine Hydrochloride is not recommended.

Pregnancy category A. This is intended for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Both Doxylamine Succinate & Pyridoxine Hydrochloride are excreted into breast milk. Therefore, caution should be exercised while breastfeeding.

Doxylamine Succinate & Pyridoxine Hydrochloride is an extended-release or Delayed Release formulation; therefore, signs and symptoms of intoxication may not be apparent immediately. Signs and symptoms of overdose may include restlessness, dryness of mouth, dilated pupils, sleepiness, vertigo, mental confusion and tachycardia. At toxic doses, Doxylamine Succinate exhibits anticholinergic effects, including seizures, rhabdomyolysis, acute renal failure and death. If treatment is needed, it consists of gastric lavage or activated charcoal, whole bowel irrigation and symptomatic treatment.

Store at below 30°C in a dry place protected from light. Keep out of reach of children.

It is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women caused by susceptible strains of Escherichia coli and Enterococcus faecalis.

Intracellular antibiotic

Fosfomycin has in vitro activity against a broad range of gram-positive and gram-negative aerobic microorganisms, associated with uncomplicated urinary tract infections. Fosfomycin Trometamol is a phosphonic acid derivative. It is a synthetic, broad spectrum, bactericidal antibiotic for oral administration. The bactericidal action of Fosfomycin is due to its inactivation of the enzyme enolpyruvyl transferase, thereby irreversibly blocking the condensation of uridine diphosphate N-acetylglucosamine with p-enolpyruvate, one of the first steps in bacterial cell wall synthesis.

The recommended dosage for women 18 years of age and older for acute cystitis is one sachet of Fosfomycin with or without food. This medicine should not used in children.

Preparation: At first pour the 100 ml purified water in a glass. Then add full contents of one Fosfomycin sachet into purified water and stir to dissolve completely. Drink full mixture immediately after preparation.

In clinical trials, the most frequently reported adverse events occurring in >1% of the study population regardless of drug relationship were: diarrhea 10.4%, headache 10.3%, vaginitis 7.6%, nausea 5.2%, rhinitis 4.5%, back pain 3.0%, dysmenorrhea 2.6%, pharyngitis 2.5%, dizziness 2.3%, abdominal pain 2.2%, pain 2.2%, dyspepsia 1.8%, asthenia 1.7%, and rash 1.4%.The following adverse events occurred in clinical trials at a rate of less than 1%, regardless of drug relationship: abnormal stools, anorexia, constipation, dry mouth, dysuria, ear disorder, fever, flatulence, flu syndrome, hematuria, infection, insomnia, lymphadenopathy, menstrual disorder, migraine, myalgia, nervousness, paresthesia, pruritus, SGPT increased, skin disorder, somnolence, and vomiting.

Fosfomycin is contraindicated in patients with known hypersensitivity to the drug and patients with severe renal insufficiency and patients undergoing haemodialysis.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Fosfomycin. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. Do not use more than one single dose of Fosfomycin to treat a single episode of acute cystitis. Repeated daily doses of Fosfomycin did not improve the clinical success or microbiological eradication rates compared to single dose therapy, but did increase the incidence of adverse events.

When Fosfomycin is coadministered with metoclopramide, which increases gastrointestinal motility, lowers the serum concentration and urinary excretion of fosfomycin. Other drugs that increase gastrointestinal motility may produce similar effects.

Fosfomycin is pregnancy category B. This drug should not be used during pregnancy unless the benefit outweighs the risk. A decision should be made to discontinue breastfeeding or to not administer the drug, taking into account the importance of the drug to the mother.

When Fosfomycin is coadministered with metoclopramide, which increases gastrointestinal motility, lowers the serum concentration and urinary excretion of fosfomycin. Other drugs that increase gastrointestinal motility may produce similar effects.

Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light.

Bempedoic acid is an adenosine triphosphate-citrate lyase (ACL) inhibitor indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.

Bempedoic acid is an adenosine triphosphate-citrate lyase (ACL) inhibitor that lowers low-density lipoprotein cholesterol (LDL-C) by inhibition of cholesterol synthesis in the liver. ACL is an enzyme upstream of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase in the cholesterol biosynthesis pathway. Bempedoic acid and its active metabolite, ESP15228, require coenzyme A (CoA) activation by very long-chain acyl-CoA synthetase 1 (ACSVL1) to ETC-1002-CoA and ESP15228-CoA, respectively. ACSVL1 is expressed primarily in the liver. Inhibition of ACL by ETC-1002-CoA results in decreased cholesterol synthesis in the liver and lowers LDL-C in blood via upregulation of low-density lipoprotein receptors.

The recommended dosage of Bempedoic acid, in combination with maximally tolerated statin therapy, is 180 mg administered orally once daily. Bempedoic acid can be taken with or without food. After initiation of Bempedoic acid, analyze lipid levels within 8 to 12 weeks.

Bempedoic acid inhibits renal tubular OAT2 and may increase blood uric acid levels. In clinical trials, 26% of Bempedoic acid-treated patients with normal baseline uric acid values (versus 9.5% placebo) experienced hyperuricemia one or more times, and 3.5% of patients experienced clinically significant hyperuricemia reported as an adverse reaction (versus 1.1% placebo). Increases in uric acid levels usually occurred within the first 4 weeks of treatment initiation and persisted throughout treatment. After 12 weeks of treatment, the mean placebo-adjusted increase in uric acid compared to baseline was 0.8 mg/dL for patients treated with Bempedoic acid.

Elevated blood uric acid may lead to the development of gout. Gout was reported in 1.5% of patients treated with Bempedoic acid and 0.4% of patients treated with placebo. The risk for gout events was higher in patients with a prior history of gout (11.2% Bempedoic acid versus 1.7% placebo), although gout also occurred more frequently than placebo in patients treated with Bempedoic acid who had no prior gout history (1.0% Bempedoic acid versus 0.3% placebo). Advise patients to contact their healthcare provider if symptoms of hyperuricemia occur. Assess serum uric acid when clinically indicated. Monitor patients for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate.

Tendon Rupture: Bempedoic acid is associated with an increased risk of tendon rupture or injury. In clinical trials, tendon rupture occurred in 0.5% of patients treated with Bempedoic acid versus 0% of placebo-treated patients and involved the rotator cuff (the shoulder), biceps tendon, or Achilles tendon. Tendon rupture occurred within weeks to months of starting Bempedoic acid. Tendon rupture may occur more frequently in patients over 60 years of age, in those taking corticosteroid or fluoroquinolone drugs, in patients with renal failure, and in patients with previous tendon disorders.

Discontinue Bempedoic acid immediately if the patient experiences rupture of a tendon. Consider discontinuing Bempedoic acid if the patient experiences joint pain, swelling, or inflammation. Advise patients to rest at the first sign of tendinitis or tendon rupture and to contact their healthcare provider if tendinitis or tendon rupture symptoms occur. Consider alternative therapy in patients with a history of tendon disorders or tendon rupture.

Simvastatin: Avoid concomitant use of Bempedoic Acid with simvastatin greater than 20 mg. Pravastatin: Avoid concomitant use of Bempedoic Acid with pravastatin greater than 40 mg.

Discontinue Bempedoic Acid when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. There are no available data on Bempedoic Acid use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There is no information regarding the presence of Bempedoic Acid in human or animal milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Breastfeeding is not recommended during treatment with Bempedoic Acid.

Pediatric Use: The safety and effectiveness of Bempedoic acid have not been established in pediatric patients.

Geriatric Use: Of the 3009 patients in clinical trials of Bempedoic acid, 1753 (58%) were 65 years and older, while 478 (16%) were 75 years and older. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.

Renal Impairment: No dosage adjustment is necessary in patients with mild or moderate renal impairment. There is limited experience with Bempedoic acid in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m 2 ), and Bempedoic acid has not been studied in patients with end-stage renal disease (ESRD) receiving dialysis.

Hepatic Impairment: No dosage adjustment is necessary in patients with mild or moderate hepatic impairment (Child-Pugh A or B. Patients with severe hepatic impairment (Child-Pugh C) have not been studied.

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

This is indicated in oral contraception.

Oral Contraceptive preparations

This is a combined oral contraceptive tablet containing the synthetic progestogen, drospirenone and the synthetic estrogen, ethinylestradiol. The contraceptive effect of this tablet is based on the interaction of various factors, the most important of which are seen as the inhibition of ovulation and the changes in cervical secretion. When this tablet is taken according to instructions, the egg cells are prevented from maturing to the point at which they can be fertilized, the cervical mucus remains thick so as to constitute a barrier to sperm and the endometrium is rendered unreceptive to implantation. As well as protection against pregnancy, estrogen/progestogen combinations have several positive properties which, next to the negative properties, can be useful in deciding on the method of birth control. The cycle is more regular and the menstruation is often less painful and bleeding is lighter.

Drospirenone has antimineralocorticoid activity, counteracting estrogen related sodium retention. In combination with ethinylestradiol, drospirenone displays a favourable lipid profile with an increase in high-density lipoprotein HDL. Drospirenone exerts antiandrogenic activity and does not counteract the ethinylestradiol-related sex hormone binding globulin (SHBG) increase which is useful for binding and inactivating the endogenous androgens. Drospirenone is devoid of any androgenic, estrogenic, glucocorticoid and antiglucocorticoid activity. This in combination with the antimineralocorticoid and antiandrogenic properties, gives drospirenone a biochemical and pharmacological profile closely resembling the natural hormone progesterone.

When and how to take the tablets: The this tablet pack contains 21 tablets. On the pack, each tablet is marked with the day of the week on which it is to be taken. Take your tablet at about the same time each day, with some water if necessary. Follow the direction of the arrows until all 21 tablets have been taken. During the next 7 days don't take any tablet. A period should begin during these 7 days (the withdrawal bleed), unusually it will start on day 2-3 after the last this tablettablet. Start taking your next pack on the 8th day even if your period continues. This means that you will always start new packs on the same day of the week and also that you have your withdrawal bleed on about the same days each month.

Starting your first pack of this tablet: When no hormonal contraceptive has been used in the past month. Start taking this tablet on the first day of your cycle, i.e. the first day of menstrual bleeding. Take a tablet marked with that day of the week. For example, if your period starts on a Sunday, take a tablet marked Sunday. Then follow thedaysin order. You may also start on days 2-5 of your cycle, but in that case make sure you also use an additional contraceptive method (barrier method) for the first 7 days of tablet-taking in the first cycle.

When changing form another combined Pill: You can start taking this tablet the day after you have the last tablet from your present Pill pack (this means no tablet-free break). If your present Pill pack also contains inactive tablets you can start this tablet on the day after taking the first active tablet (if you are not sure which this is, ask your doctor or pharmacist). You can also start later, but never later than the day following the tablet free break of your present Pill (or the day after the last inactive tablet of your present Pill).

When changing from progestogen-only Pill (Mini Pill): You can stop taking the mini pill any day and start taking this tablet the next day, at the same time. But make sure you also use an additional-contraceptive method (a barrier method) for the first 7 days of tablet-taking when having intercourse.

When changing from an Injectable or Implant: Start using this tablet when your next injection is due or on the day that your implant is removed. But make sure you also use an additional contraceptive method (a barrier method) for the first 7 days of tablet-taking when having intercourse.

After having a baby: If you have just had a baby, your doctor may tell you to wait until after your first normal period before you start taking this tablet. Sometimes it is possible to start sooner. Your doctor will advise you. If you are breast-feeding and want to take this tablet you should discuss this first with your doctor.

After a miscarriage or an abortion: Your doctor will advise you.

If too many this tablet tablets are taken (overdose): There have been no reports of serious harmful effects from taking too many this tablet tablets at one time. If you have taken several tablets at a time, you may have nausea, vomiting or vaginal bleeding. If you discover that a child has taken this tablet ask your doctor for advice.

When you want to stop taking this tablet: You can stop taking this tablet at any time you want. If you do not want to become pregnant, ask your doctor about other methods of birth control. If you stop taking this tablet because you want to get pregnant, it is generally recommended that you wait until you have had a natural period before trying to conceive.

If you forget to take tablets

• If you are less than 12 hours late in taking a tablet, the reliability of the Pill is maintained. Take the tablet as soon as you remember and take the next tablets at the usual times.
• If you are more than 12 hours late in taking any tablet, the reliability of the Pill may be reduced. The more consecutive tablets you have missed, the higher the risk that the contraceptive efficacy is decreased. There is a particularly high risk of becoming pregnant if you miss tablets at the beginning or at the end of the pack. Therefore, you should follow the rules given below.

More than one tablet forgotten in a pack: Ask your doctor for advice.

• 1 tablet missed in week 1: Take the missed tablet as soon as your remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. Use extra contraceptive precautions (barrier method) for the next 7 days. If you had sexual intercourse in the week before missing the tablets, there is a possibility of becoming pregnant. So tell your doctor immediately.
• 1 tablet missed in week 2: Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. The reliability of the Pill is maintained. You need not use extra contraceptive precautions.
• 1 tablet missed in week 3: You may choose either of the following options, without the need for extra contraceptive precautions.

Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. Start the next pack as soon as the current pack is finished so that no gap is left between packs. You may not have a withdrawal bleed until the end of the second pack but you may have spotting or breakthrough bleeding on tablet-taking days. Or

Stop taking tablets from your current pack, have a tablet-free break of 7 days or less (also count the day you missed your tablet) and continue with the next pack. When, following this method, you can always start your next pack on the same day of the week as you usually do.

If you have forgotten tablets in a pack and you do not have the expected period in the first normal tablet-free break, you may be pregnant. Consult your doctor before you start with the next pack.

you vomit: If you vomit within 3 to 4 hours after taking your this tablet tablet, the active ingredients may not have been completely absorbed. This is like missing a tablet. Therefore, follow the advice for missed tablets.

you want to delay your period: you can delay your period if you start with your next pack of this tablet immediately after finishing your current pack. You can continue with this pack for as long as you wish, until this pack is empty. When you wish your period to begin, just stop tablet taking. While using the second pack you may have some breakthrough bleeding or spotting on tablet-taking days. Start with your next pack after the usual 7 days tablet free break.

you want to change the starting day of your period: If you take your tablets as directed, you will have your period on about the same day every 4 weeks. If you want to change this, just shorten, (never lengthen) the next tablet- free break. For example, if your period usually starts on a Friday and in future you want it to start on Tuesday (3 days earlier) you should now start your next pack 3 days sooner than you usually do. If you make your tablet-free break very short (e.g. 3 days or less) you may not have bleeding during the break. You may have some breakthrough bleeding or spotting during the use of the next pack.

you have unexpected bleeding: With all Pills, for the first few months, you can have irregular vaginal bleeding (spotting or breakthrough bleeding) between your periods. You may need to use sanitary protection, but continue to take your tablets as normal. Irregular vaginal bleeding usually stops once your body has adjusted to the Pill (usually after about 3 tablet-taking cycles). If it continues, becomes heavy or starts again, tell your doctor.

you have missed a period: If you have taken all of your tablets at the right time and you have not vomited or used other medicines then you are very unlikely to be pregnant. Continue to take this tablet as usual.

If you miss your period twice in row, you may be pregnant. Tell your doctor immediately. Do not start the next pack of this tablet until your doctor has checked you are not pregnant.

Like other contraceptives some undesirable effects may have seen with this tablet, these include venous and arterial thromboembolic disorders. The following undesirable effects have been reported in users of COCs and whether this association is causal has not been confirmed: Nausea, abdominal pain, Vomiting, diarrhoea, Weight increased, Fluid retention, Headache, Migraine, Depressed mood, mood altered, Breast pain, breast tenderness, Libido decreased, Breast hypertrophy, Rash, urticaria. In women with hereditary angioedema exogenous estrogens may induce or exacerbate symptoms of angioedema.

Preparations containing estrogen/progestogen combinations should not be used in the presence of any of the conditions listed below. If any of the conditions appear for the first time during their use, the product should be stopped immediately.

• Thrombosis (venous or arterial) present or in history (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident)
• Presence or history of prodromi of a thrombosis (e.g.transient ischaemic attack, angina pectoris)
• Presence or history of migraine with focal neurological symptoms
• Diabetes mellitus with vascular involvement
• Disturbed lipometabolism
• The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis may also constitute a contraindication
• Pancreatitis or a history thereof if associated with severe hypertriglyceridemia
• Presence or history of severe hepatic disease as long as liver function values have not returned to normal
• Severe renal insufficiency or acute renal failure
• Presence or history of liver tumours (benign or malignant)
• Known or suspected malignant conditions of the genital organs or the breasts, if sex steroid-influenced
• Undiagnosed vaginal bleeding
• Known or suspected pregnancy
• Hypersensitivity to any of the components of this tablet.

The clinical and epidemiological evidence for estrogen/progestogen combinations like this tablet is predominantly based on experience with COCs in general. Therefore, the following warnings related to the use of COCs apply also to the use of this tablet. Also, increased risk of arterial, venous thrombotic and thromboembolic diseases such as myocardial infarction, deep venous thrombosis, pulmonary embolism and of cerebrovascular accidents. These events occur rarely.

• Cervical cancer
• Hypertriglyceridemia
• Blood pressure
• Jaundice
• Erythematosus
• Haemolytic uraemic syndrome
• Sydenham's chorea
• Herpes gestationis
• Otosclerosis-related hearing loss.
• Hereditary angioedema
• Acute or chronic disturbances of liver or kidney
• Crohn's disease and ulcerative colitis
• Chloasma

The Pill and other Medicines: Some medicines may stop the Pill from working properly. These include medicines used for the treatment of epilepsy (e.g. primidone, phenyton, barbiturates) and tuberculosis (e.g. rifampicin); and antibiotics (e.g. ampilicllin, tetracyclines, griseofulvin); for some other infectious diseases. Always tell the doctor, who prescribes the Pill, which medicines you are already using. Also tell other doctor/dentist who prescribes another medicine (or the dispensing pharmacist) that you use this tablet. They can tell you if you need to take additional contraceptive precautions and if so, for how long.

The Pill and Ability to Drive: There are no observed effects.

The Pill and Breastfeeding: This tablet is generally not recommended for use during breast feeding. If you wish to take the Pill while breastfeeding, please seek the advice of your doctor.

The Pill and Pregnancy: This tablet must not be used by women who are pregnant or who think they may be pregnant.

Store below 30°C. Store all drugs properly and keep them out of reach of children.

This tablet is indicated for:

• As an oral contraceptive
• Treatment of moderate acne vulgaris
• Treatment of premenstrual dysphoric disorder (PMDD)

Oral Contraceptive preparations

This contains two active ingredients- Ethinylestradiol and Drospirenone. Ethinylestradiol is a synthetic version of estrogen and Drospirenone is a synthetic form of progesterone. The hormonal components of this preparation inhibit ovulation by suppressing gonadotropin release. Secondary mechanisms, which may contribute to the effectiveness of this tablet as a contraceptive, include changes in the cervical mucus (which increase the difficulty of sperm penetration) and changes in the endometrium (which reduce the likelihood of implantation).

Drospirenone has antimineralocorticoid activity, counteracting estrogen-related sodium retention. In combination with Ethinyloestradiol, Drospirenone displays a favorable lipid profile with an increase in high-density lipoprotein HDL. Drospirenone exerts antiandrogenic activity and does not counteract the ethinyloestradiol-related sex hormone-binding globulin increase which is useful for binding and inactivating the endogenous androgens.

To achieve maximum contraceptive effectiveness tablets must be taken in the order directed on the package every day at about the same time. Tablet-taking should be started with the first pink tablet of the upper row & have to continue daily for 24 consecutive days. After completion of pink tablet, white tablet should be taken from 25th day to 28th day. Withdrawal bleeding usually starts on days 2-3 after starting the white tablets & don't stop taking white tablets though your menstruation is already started. Each subsequent new pack is started on the day after the last white tablet of the previous pack.

No preceding hormonal contraceptive use in the past month: Tablet taking has to start on day 1 of the woman’s menstrual cycle. The woman should be instructed to take the first light pink active tablet from the upper row of this tablet according to the direction and in this case no additional methods of contraception are required. Starting on days 2-5 is allowed, but during the first cycle a barrier method is recommended in addition for the first 7 days of tablet-taking.

Changing from another combined hormonal pill or vaginal ring or transdermal patch: In case of combined hormonal pill, woman should start with the first light pink tablet of upper row on the day after the last active tablet of her previous COC. In case of a vaginal ring or transdermal patch has been used, the woman should start using this tablet preferably on the day of removal.

Changing from a progestogen-only-method (minipill, injection, implant) or from a progestogen-releasing intrauterine system (IUS): The woman may switch any day from the minipill (or from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due), but should in all of these cases be advised to additionally use a barrier method (like-condom) for the first 7 days of tablet-taking.

Following first-trimester abortion: The woman may start immediately and in this case no need to take additional contraceptive method.

Following delivery or second-trimester abortion: Women are advised to start at day 21 to 28 after delivery or second-trimester abortion. When starting later, the woman are advised to additionally use a barrier method (like-condom) for the first 7 days of tablet-taking.

Management of Missed Tablets: Missed white pills from the last row of the blister are placebo tablets and thus can be disregarded. But if you forgot to take a light pink tablet one day, take the missed tablet as soon as you remember. This may mean taking two tablets the very next day. Additionally you should use some other method of contraception (like a condom) until next 7 days. If you forget to take the tablets for two continuous days, then it is likely that you will no longer be protected against pregnancy. You should therefore discontinue taking the tablet and adopt some other temporary methods (condom/foam tablet) till your next menstruation. Discard the unfinished pack of tablets and start taking tablets from the light pink tablet of the top row of a fresh pack from the first day of next menstruation.

If you have missed a period after taking tablet: If you have taken all of your pills at the right time and you have not vomited or used other medicines then you are very unlikely to be pregnant. Continue to take tablet as usual. If you miss your period twice in a row, you may be pregnant. Tell your doctor immediately. Do not start the next pack of this tablet until your doctor has checked you are not pregnant.

How to Delay a Period: To delay period women should continue with another new pack of this tablet just after finishing the light pink active tablet of the present pack (that is no need to take white placebo tablet of present pack). The extension can be carried on for as long as wished until the end of light pink color tablet of the second pack. When women wish their period to begin, just stop tablet taking. While using the second pack woman may have some breakthrough bleeding or spotting. Start with your next pack after the usual 4 day white inactive tablet interval.

Advice in case of Vomiting: If vomiting occurs within 3-4 hours after light pink tablet taking, absorption may not be complete. In such an event, the advice concerning management of missed tablets is applicable. The woman must take the extra active tablet (light pink color) needed from a back up pack after vomiting.

Different types of tablet suit to different types of woman. At the initial stage some women may experience side-effects like dizziness, headache, breast pain, nausea or unscheduled uterine bleeding. These symptoms may occur in >3% of users. After starting one brand of oral contraceptive tablets, if you feel any inconvenience such as migraine, changes in eyesight or speech, unusual pain or swelling in your legs, sharp chest pains or shortness of breath, rash, yellow skin or a rise in blood pressure take immediate advice from your doctor.

This tablet should not be used:

• Known or suspected pregnancy
• If you have heart disease, clotting of blood in the vein
• If you suffer from liver disease or jaundice
• If you suffer from high blood pressure, migraine, feel something hard in your breast, diabetes with vascular involvement, experience excessive bleeding for which no reason has yet been ascertained
• The presence or a history of venous or arterial thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction or of a cerebrovascular accident)
• History of migraine with focal neurological symptoms
• Pancreatitis or a history thereof if associated with severe hypertriglyceridaemia
• Severe renal insufficiency or acute renal failure
• Presence or history of liver tumours (benign or malignant)
• Undiagnosed vagina! bleeding
• Hypersensitivity to any of the components of this preparation.

If any circulatory disorder (like- myocardial infarction, deep venous thrombosis, pulmonary embolism, cerebrovascular injury etc) or other risk factors(like smoking, obesity, hypertension, dyslipidemia, migraine, atrial fibrillation etc) are present, the benefits of COC use should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start using it. In the event of aggravation, exacerbation or first appearance of any of these conditions or risk factors after taking pill, the woman should contact with her physician. The physician should then decide on whether its use should be discontinued.

Interactions between ethinylestradiol and other drugs may lead to decreased or increased ethinylestradiol concentrations, respectively. Decreased ethinylestradiol serum concentrations may cause an increased incidence of breakthrough bleeding and menstrual irregularities and may possibly reduce efficacy of the oral contraceptive. Example of substances that may decrease serum ethinylestradiol concentrations include rifampicin, phenytoin, primidone, rifabutin, dexamethasone, griseofulvin, topiramate, some protease inhibitors, modafinil, ritonavir and barbiturates. Certain antibiotics including ampicillin, other penicillins and tetracyclines may reduce the efficacy of oral contraceptives. During concomitant use of this tablet & other drugs that may lead to decreased ethinylestradiol serum concentrations, it is recommended that a non hormonal back-up method of contraception to be used in addition to the regular intake of this tablet.

Use during pregnancy: This is contraindicated during pregnancy. Pregnancy must be excluded before starting this tablet. If pregnancy occurs during use of this tablet, the preparation must be withdrawn immediately. Women who discontinue oral contraceptives with the intent of becoming pregnant, a non-hormonal method of contraception is recommended for three months before attempting to conceive.

Use during lactation: Lactation may be influenced by combined pill as they may reduce the quantity and change the composition of breast milk, therefore the use of estrogen containing combined pill should generally not be recommended until the nursing mother has completely weaned her child. Small amounts of the contraceptive steroids and/or their metabolites may be excreted with the milk.

Pediatric Use: This is only indicated after menarche. There is no data suggesting the need for a dosage adjustment.

Use in the Elderly: This is not indicated after menopause.

Symptoms of oral contraceptive overdose may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue; withdrawal bleeding may occur in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.

Do not store above 30°C. Keep away from light and out of the reach of children.

This is indicated to relieve symptoms of dyspepsia, heartburn, acid indigestion, sour stomach, gastroesophageal reflux and hiatal hernia. It is also prescribed in hyperacidity associated with peptic ulcers, gastritis and esophagitis. Magaldrate may be given to children if necessary. Also indicated for the relief of flatulence, abdominal distension and windy colic.

Antacids, Anti-dyspeptic/Carminatives

This is a combination of magaldrate and simethicone. Magaldrate (magnesium aluminium compound i.e. Hydroxymagnesium Aluminate), which neutralizes gastric acid extraordinarily quickly without raising the pH above 5-6. It also decreases the activity of pepsin in gastric secretion. Besides this, simethicone, the another component of Marlox Plus, enables the gas buble to coalesce and give relief from flatulence.

Tablet: 1-4 chewable tablets, 20 to 60 minutes after meals and at bedtime, or as directed by the physician.
Suspension: 2-4 teaspoonfuls (10-20 ml) of suspension, 20 to 60 minutes after meals and at bed time, or as directed by the physician.

Gastrointestinal side-effects are uncommon. Occasionally, if excessive amount is consumed, diarrhea, constipation or regurgitation may occur.

Magaldrate is contraindicated in patients with known hypersensitivity to magnesium and aluminium. It is also contraindicated in patients with impaired renal functions.

Care should be taken in decreased kidney function, hypophosphataemia and weak people.

It should not be used in patients taking any form of Tetracycline. The drug may cause reduced bio-availability or slower absorption of a number of drugs including propranolol, isoniazid, prednisolone and naproxen.

Magaldrate may be used in pregnancy if indicated however one should avoid excessive dosage. Magaldrate may pass into breast milk but has not been reported to cause problem in nursing babies.

Over dosage with this formulation is a rare case.

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

This is indicated to relieve symptoms of dyspepsia, heartburn, acid indigestion, sour stomach, gastroesophageal reflux and hiatal hernia. It is also prescribed in hyperacidity associated with peptic ulcers, gastritis and esophagitis. Magaldrate may be given to children if necessary. Also indicated for the relief of flatulence, abdominal distension and windy colic.

Antacids, Anti-dyspeptic/Carminatives

This is a combination of magaldrate and simethicone. Magaldrate (magnesium aluminium compound i.e. Hydroxymagnesium Aluminate), which neutralizes gastric acid extraordinarily quickly without raising the pH above 5-6. It also decreases the activity of pepsin in gastric secretion. Besides this, simethicone, the another component of Marlox Plus, enables the gas buble to coalesce and give relief from flatulence.

Tablet: 1-4 chewable tablets, 20 to 60 minutes after meals and at bedtime, or as directed by the physician.
Suspension: 2-4 teaspoonfuls (10-20 ml) of suspension, 20 to 60 minutes after meals and at bed time, or as directed by the physician.

Gastrointestinal side-effects are uncommon. Occasionally, if excessive amount is consumed, diarrhea, constipation or regurgitation may occur.

Magaldrate is contraindicated in patients with known hypersensitivity to magnesium and aluminium. It is also contraindicated in patients with impaired renal functions.

Care should be taken in decreased kidney function, hypophosphataemia and weak people.

It should not be used in patients taking any form of Tetracycline. The drug may cause reduced bio-availability or slower absorption of a number of drugs including propranolol, isoniazid, prednisolone and naproxen.

Magaldrate may be used in pregnancy if indicated however one should avoid excessive dosage. Magaldrate may pass into breast milk but has not been reported to cause problem in nursing babies.

Over dosage with this formulation is a rare case.

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

This preparation is indicated in Gastric reflux, Heartburn, Flatulence associated with gastric reflux, Heartburn of pregnancy, All cases of epigastric and retrosternal distress where the underlying cause is gastric reflux.

Antacids

The mode of action of the product is physical and does not depend on absorption into the systemic circulation. On ingestion, the product reacts rapidly with gastric acid to form a raft of Alginic acid gel having a near-neutral pH and which floats on the stomach contents quickly and effectively impeding gastro-esophageal reflux, for up to 4 hours. In severe cases, the raft itself may be refluxed into the esophagus in preference to the stomach contents and exert a demulcent effect.

For oral administration:

Adult and children over 12 years:10-20 mL after meals and at bedtime, up to four times a day.

Children 6 to 12 years: 5-10 mL after meals and at bedtime, up to four times a day.

Children under 6 years: Not recommended.

Elderly: No dosage modification is required for this age group.

In addition to the desired effect of the drug, some side effects may appear such as: constipation, flatulence, stomach cramp or belching. In these cases consult a physician. If too big dose has been taken, there might appear a sensation of swelling. In this case, it is advisable to consult a physician.

This product is contraindicated in patients with known or suspected hypersensitivity to the active ingredients or to any of the excipients.

If symptoms do not improve after 7 days, the clinical situation should be reviewed. Each 10 mL dose has a Sodium content of 141 mg (6.2 mmoL). This should be taken into account when a highly restricted salt diet is recommended, e.g. in some cases of congestive cardiac failure and renal impairment. Each 10 mL dose contains 160 mg (1.6 mmoL) of Calcium Carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.

A time-interval of 2 hours should be considered between this drug intake and the administration of other medicinal products, especially Tetracyclines, Digoxine, Fluoroquinolone, Iron salt, Ketoconazole, Neuroleptics, Thyroid Hormones, Penicillamine, beta-blockers (Atenolol, Metoprolol, Propranolol), Glucocorticoid, Chloroquine and Biphosphonates (diphosphonates) and Estramustine.

Pregnancy: Clinical studies in more than 500 pregnant women, as well as a large amount of data from post-marketing experience, indicate no malformative nor feto/neonatal toxicity of the active ingredients. This drug can be used during pregnancy, if clinically needed.

Breastfeeding: No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. This drug can be used during breastfeeding.

Fertility: Pre-clinical investigations have revealed Alginate has no negative effect on parental or offspring fertility or reproduction. Clinical data do not suggest that this drug has an effect on human fertility.

In the event of over dosage symptomatic treatment should be given. The patient may notice abdominal distension.

Store in a cool (below 30°C) and dry place, away from light. Keep out of the reach of children. Do not refrigerate or freeze.

Xylometazoline is indicated in-

• Nasal congestion in colds, rhinitis, sinusitis, headache.
• Tubal block and serous otitis media associated with nasal congestion.

Nasal Anti-histamine preparations

Nasal congestion is caused by various etiologies, such as rhinosinusitis and allergic or non-allergic rhinitis, leading to congestion of the venous sinusoids lining the nasal mucosa. Activation of α-adrenergic receptors leads to vasoconstriction of the blood vessels of the nasal mucosa and resumption of nasal airflow. As the most abundantly expressed in the human nasal mucosa, α_1A- and α_2B-adrenoceptors may play the most important role in vasoconstriction of the human nasal mucosa. Xylometazoline is a more selective agonist at α_2B-adrenoceptors, with affinity at α_1A-, α_2A-, α_2C-, α_1B-, and α_1D-adrenoceptors. Xylometazoline decreases nasal resistance during inspiration and expiration and increases the volume of nasal airflow. Compared to oxymetazoline, another imidazoline nasal decongestant, xylometazoline had a slightly faster onset of action although they had a similar duration of action. In one study, subjects with nasal congestion reported relief of earache and sore throat in addition to nasal decongestion: it is speculated that oxymetazoline mediates this effect by causing vasoconstriction of the nasal mucosa that contains the venous sinuses and nasal decongestion allows breathing through the nose, providing relief from sore throat caused by mouth breathing that dries and irritates the throat.

Adults: Xylometazoline 0.1%: 2 or 3 drops in each nostril two to three times daily. Xylometazoline 0.1% should not be used for children under the age of 12 years.

Children 6 to 12 years of age: Xylometazoline 0.05%: 2 or 3 drops in each nostril two or three times daily.

Children less than 6 years of age: Xylometazoline 0.05%: 1 drop in each nostril two or three times daily.

Infants less than 3 months: Not to be used in infants less than 3 months.

The following side-effects have occasionally been encountered:

• A burning sensation in the nose and throat
• Local irritation
• Nausea and dryness of the nasal mucosa.

Xylometazoline nasal drops is contraindicated in patients with transsphenoidal hypophysectomy or surgery exposing the dura mater. It is also contraindicated in patients who are hypersensitive to Xylometazoline. Each Xylometazoline nasal drop should be used by one person only to prevent any cross-infection. Patients are advised not to take decongestants for more than seven consecutive days.

Xylometazoline Hydrochloride nasal drops for adults (0.1%) should not be used for children below 12 years. Drops should not be used for long time in cases with chronic rhinitis. Prolonged use of the drops may cause rebound congestion and drug induced rhinitis.

No drug interactions have been reported.

Pregnancy category C. Xylometazoline should not be used during pregnancy. The use of Otrivin while breastfeeding should only take place on the instructions of a doctor.

Protect from light. For reasons of hygiene, do not use the bottle more than 28 days after opening it.

Xylometazoline is indicated in-

• Nasal congestion in colds, rhinitis, sinusitis, headache.
• Tubal block and serous otitis media associated with nasal congestion.

Nasal Anti-histamine preparations

Nasal congestion is caused by various etiologies, such as rhinosinusitis and allergic or non-allergic rhinitis, leading to congestion of the venous sinusoids lining the nasal mucosa. Activation of α-adrenergic receptors leads to vasoconstriction of the blood vessels of the nasal mucosa and resumption of nasal airflow. As the most abundantly expressed in the human nasal mucosa, α_1A- and α_2B-adrenoceptors may play the most important role in vasoconstriction of the human nasal mucosa. Xylometazoline is a more selective agonist at α_2B-adrenoceptors, with affinity at α_1A-, α_2A-, α_2C-, α_1B-, and α_1D-adrenoceptors. Xylometazoline decreases nasal resistance during inspiration and expiration and increases the volume of nasal airflow. Compared to oxymetazoline, another imidazoline nasal decongestant, xylometazoline had a slightly faster onset of action although they had a similar duration of action. In one study, subjects with nasal congestion reported relief of earache and sore throat in addition to nasal decongestion: it is speculated that oxymetazoline mediates this effect by causing vasoconstriction of the nasal mucosa that contains the venous sinuses and nasal decongestion allows breathing through the nose, providing relief from sore throat caused by mouth breathing that dries and irritates the throat.

Adults: Xylometazoline 0.1%: 2 or 3 drops in each nostril two to three times daily. Xylometazoline 0.1% should not be used for children under the age of 12 years.

Children 6 to 12 years of age: Xylometazoline 0.05%: 2 or 3 drops in each nostril two or three times daily.

Children less than 6 years of age: Xylometazoline 0.05%: 1 drop in each nostril two or three times daily.

Infants less than 3 months: Not to be used in infants less than 3 months.

The following side-effects have occasionally been encountered:

• A burning sensation in the nose and throat
• Local irritation
• Nausea and dryness of the nasal mucosa.

Xylometazoline nasal drops is contraindicated in patients with transsphenoidal hypophysectomy or surgery exposing the dura mater. It is also contraindicated in patients who are hypersensitive to Xylometazoline. Each Xylometazoline nasal drop should be used by one person only to prevent any cross-infection. Patients are advised not to take decongestants for more than seven consecutive days.

Xylometazoline Hydrochloride nasal drops for adults (0.1%) should not be used for children below 12 years. Drops should not be used for long time in cases with chronic rhinitis. Prolonged use of the drops may cause rebound congestion and drug induced rhinitis.

No drug interactions have been reported.

Pregnancy category C. Xylometazoline should not be used during pregnancy. The use of Otrivin while breastfeeding should only take place on the instructions of a doctor.

Protect from light. For reasons of hygiene, do not use the bottle more than 28 days after opening it.

Aciclovir is indicated for-

• The treatment of viral infections due to Herpes simplex virus (type I & II) and Varicella zoster virus (herpes zoster & chicken pox).
• The treatment of Herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital herpes and herpes labialis.
• The prophylaxis of Herpes simplex infections in immunocompromised patients

Herpes simplex & Varicella-zoster virus infections

Aciclovir is a synthetic purine derivative. Aciclovir exerts its antiviral effect on Herpes simplex virus (HSV) and Varicella-zoster virus by interfering with DNA synthesis and inhibiting viral replication. In cells infected with herpes virus, the antiviral activity of Aciclovir appears to depend principally on the intracellular conversion of the drug to Aciclovir Triphosphate. Aciclovir is converted to Aciclovir Monophosphate principally via virus coded thymidine kinase; the monophosphate is phosphorylated to the diphosphate via cellular guanylate kinase and then via another cellular enzyme to the triphosphate, which is the pharmacologically active form of the drug. 15-30% of an oral dose of the drug is absorbed from Gl tract. Peak plasma concentrations usually occur within 1.5-2 hours after oral administration. It is widely distributed into body tissues and fluids including the brain, saliva, lungs, liver, muscle, spleen, uterus, vaginal mucosa and secretions, CSF, and herpetic vesicular fluid. Aciclovir is excreted through the kidney by the glomerular filtration & tubular secretion.

Treatment of initial herpes simplex: 200 mg 5 times daily usually for 5 days.

For immunocompromised patients:

• Adult: 400 mg 5 times daily for 5 days (longer if new lesions appear during treatment or if healing is incomplete; increase dose to 800 mg 5 times daily for genital herpes in immunocompromised) or as directed by the registered physician.
• Children under 2 years: Half of the adult dose.
• Children over 2 years: Adult dose.

Prevention of recurrence of herpes simplex:

• Adult: 200 mg 4 times daily or 400 mg twice daily possibly reduced to 200 mg 2 or 3 times daily and interrupted every 6-12 months.
• Children under 2 years: Half of the adult dose.
• Children over 2 years: Adult dose.

Prophylactic treatment of herpes simplex in the immunocompromised patients:

• Adult: 200 to 400 mg 4 times daily.
• Children under 2 years: Half of the adult dose.
• Children over 2 years: Adult dose.

Treatment of vericella (chicken pox):

• Adult and children over 40 kg: 800 mg 4 times daily for 5 days.
• Children below 40 kg: 20 mg/kg (maximum 800 mg) per dose orally 4 times daily (80 mg/kg/day) for 5 days.
• Children 1 month-2 years: 200 mg 4 times daily for 5 days.
• Children 2-5 years:400 mg 4 times daily for 5 days.
• Children 6-12 years:800 mg 4 times daily for 5 days.

Treatment of herpes zoster (Shingles): 800 mg 5 times daily for 7 days.

Treatment of initial rectal (Proctitis) herpes infections: An oral Aciclovir dosage of 400 mg 5 times daily for 10 days or until clinical resolution occurs has been recommended.

Renal Impairment: For patients with severe renal impairment, a reduction of the doses is recommended.

Rash, gastrointestinal disturbance, rise in bilirubin and liver-related enzymes, increase in blood urea and creatinine, decrease in hematological indices, headache, neurological reaction, fatigue.

Aciclovir is contraindicated in patients known to be hypersensitive to Aciclovir.

Aciclovir should be administered with caution in patients with renal impairment and doses should be adjusted according to creatinine clearance. Monitor neutrophil count at least twice weekly in neonates.

Probenecid reduces Aciclovir excretion and so increases plasma concentration and risk of toxicity.

Pregnancy category B. Aciclovir should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Caution should be exercised when it is administered to a nursing mother.

Should be stored below 25°C. It should be protected from light and moisture.Keep out of the reach of children.

Aciclovir is indicated for-

• The treatment of viral infections due to Herpes simplex virus (type I & II) and Varicella zoster virus (herpes zoster & chicken pox).
• The treatment of Herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital herpes and herpes labialis.
• The prophylaxis of Herpes simplex infections in immunocompromised patients

Herpes simplex & Varicella-zoster virus infections

Aciclovir is a synthetic purine derivative. Aciclovir exerts its antiviral effect on Herpes simplex virus (HSV) and Varicella-zoster virus by interfering with DNA synthesis and inhibiting viral replication. In cells infected with herpes virus, the antiviral activity of Aciclovir appears to depend principally on the intracellular conversion of the drug to Aciclovir Triphosphate. Aciclovir is converted to Aciclovir Monophosphate principally via virus coded thymidine kinase; the monophosphate is phosphorylated to the diphosphate via cellular guanylate kinase and then via another cellular enzyme to the triphosphate, which is the pharmacologically active form of the drug. 15-30% of an oral dose of the drug is absorbed from Gl tract. Peak plasma concentrations usually occur within 1.5-2 hours after oral administration. It is widely distributed into body tissues and fluids including the brain, saliva, lungs, liver, muscle, spleen, uterus, vaginal mucosa and secretions, CSF, and herpetic vesicular fluid. Aciclovir is excreted through the kidney by the glomerular filtration & tubular secretion.

Treatment of initial herpes simplex: 200 mg 5 times daily usually for 5 days.

For immunocompromised patients:

• Adult: 400 mg 5 times daily for 5 days (longer if new lesions appear during treatment or if healing is incomplete; increase dose to 800 mg 5 times daily for genital herpes in immunocompromised) or as directed by the registered physician.
• Children under 2 years: Half of the adult dose.
• Children over 2 years: Adult dose.

Prevention of recurrence of herpes simplex:

• Adult: 200 mg 4 times daily or 400 mg twice daily possibly reduced to 200 mg 2 or 3 times daily and interrupted every 6-12 months.
• Children under 2 years: Half of the adult dose.
• Children over 2 years: Adult dose.

Prophylactic treatment of herpes simplex in the immunocompromised patients:

• Adult: 200 to 400 mg 4 times daily.
• Children under 2 years: Half of the adult dose.
• Children over 2 years: Adult dose.

Treatment of vericella (chicken pox):

• Adult and children over 40 kg: 800 mg 4 times daily for 5 days.
• Children below 40 kg: 20 mg/kg (maximum 800 mg) per dose orally 4 times daily (80 mg/kg/day) for 5 days.
• Children 1 month-2 years: 200 mg 4 times daily for 5 days.
• Children 2-5 years:400 mg 4 times daily for 5 days.
• Children 6-12 years:800 mg 4 times daily for 5 days.

Treatment of herpes zoster (Shingles): 800 mg 5 times daily for 7 days.

Treatment of initial rectal (Proctitis) herpes infections: An oral Aciclovir dosage of 400 mg 5 times daily for 10 days or until clinical resolution occurs has been recommended.

Renal Impairment: For patients with severe renal impairment, a reduction of the doses is recommended.

Rash, gastrointestinal disturbance, rise in bilirubin and liver-related enzymes, increase in blood urea and creatinine, decrease in hematological indices, headache, neurological reaction, fatigue.

Aciclovir is contraindicated in patients known to be hypersensitive to Aciclovir.

Aciclovir should be administered with caution in patients with renal impairment and doses should be adjusted according to creatinine clearance. Monitor neutrophil count at least twice weekly in neonates.

Probenecid reduces Aciclovir excretion and so increases plasma concentration and risk of toxicity.

Pregnancy category B. Aciclovir should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Caution should be exercised when it is administered to a nursing mother.

Should be stored below 25°C. It should be protected from light and moisture.Keep out of the reach of children.

Acyclovir cream is a herpes simplex virus (HSV) nucleoside analogue DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older.

Topical Antiviral preparations

Acyclovir is an antiviral drug active against herpes simplex virus. Acyclovir is a synthetic purine nucleoside analogue with cell culture and in vivo inhibitory activity against HSV types 1 (HSV-1) and 2 (HSV-2). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In cell culture, acyclovir triphosphate stops replication of herpes viral DNA. This inhibition is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase.

Acyclovir cream should be applied five times per day for four days. Therapy should be initiated as early as possible following the onset of signs or symptoms of herpes labialis i.e., during the prodrome or when lesions appear. For adolescents 12 years of age and older, the dosage is the same as in adults.

The most common adverse reactions at the site of topical application were dry lips, desquamation, dryness of skin, cracked lips, burning skin, pruritus, flakiness of skin, and stinging on skin; each adverse reaction occurred in less than 1% of patients receiving Acyclovir cream and placebo. Three patients on Acyclovir cream and one patient on placebo discontinued treatment due to an adverse event.

Acyclovir cream is contraindicated in patients with known hypersensitivity to acyclovir, valacyclovir, or any component of the formulation.

Acyclovir cream should only be applied on the affected external aspects of the lips and face in patients with herpes labialis. Because no data are available, application to human mucous membranes is not recommended. Acyclovir cream is intended for cutaneous use only and should not be used in the eye or inside the mouth or nose. Cream has a potential for irritation and contact. The effect of Acyclovir cream has not been established in immunocompromised patients.

Clinical experience has identified no interactions resulting from topical or systemic administration of other drugs concomitantly with Acyclovir cream. Due to minimal systemic absorption of Acyclovir cream, systemic drug interactions are unlikely.

Pregnancy Category B. There are no adequate and well-controlled studies of acyclovir cream in pregnant women. Acyclovir cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether topically applied acyclovir is excreted in breast milk. Systemic exposure following topical administration is minimal.

Pediatric Use: An open-label, uncontrolled trial with Acyclovir cream 5% was conducted in 113 patients aged 12 to 17 years with recurrent herpes labialis. In this trial, therapy was applied using the same dosing regimen as in adults and subjects were followed for adverse events. The safety profile was similar to that observed in adults. Safety and effectiveness in pediatric patients less than 12 years of age have not been established.

Geriatric Use: Clinical studies of acyclovir cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Systemic absorption of acyclovir after topical administration is minimal.

Store Acyclovir cream at room temperature between 20°C to 25°C

Acyclovir & Hydrocortisone Cream is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and children (6 years of age and older).

Hydrocortisone & Combined preparations

Acyclovir is a synthetic purine nucleoside analogue with inhibitory activity against Herpes simplex viruses type 1 (HSV-1) and type 2 (HSV-2) in cell culture and in vivo. The inhibitory activity of Acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV. This viral enzyme converts Acyclovir into Acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In cell culture, Acyclovir Triphosphate stops replication of herpes viral DNA. This inhibition is accomplished in 3 ways:

• Competitive inhibition of viral DNA polymerase
• Incorporation into and termination of the growing viral DNA chain
• Inactivation of the viral DNA polymerase

Hydrocortisone is the main glucocorticoid secreted by the adrenal cortex. It is used topically for its anti-inflammatory effects which suppress the clinical manifestations of the disease in a wide range of disorders where inflammation is a prominent feature.

The cream should be topically applied 5 times per day for 5 days. Therapy should be initiated as early as possible after the first signs and symptoms.

The following most common adverse reactions (<1%) were local skin reactions like drying or flaking of the skin; burning or tingling, erythema; pigmentation changes, application site reactions including signs and symptoms of inflammation.

There is no known contraindication.

Acyclovir and Hydrocortisone should not be used in the eye, inside the mouth or nose, or on the genitals. Patients should seek medical advice when a cold sore fails to heal within 2 weeks.

Pregnancy Category B. There are no adequate and well-controlled studies of systemic Acyclovir in pregnant women. No studies have been performed in pregnant women. Systemic exposure of Acyclovir and Hydrocortisone following topical administration of this cream is minimal. It is not known whether topically applied Acyclovir or Hydrocortisone is excreted in breast milk. Because many drugs are excreted in human milk, caution should be exercised when administered to a nursing woman.

Safety and effectiveness in pediatric subjects less than 6 years of age have not been established.

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

Biphasic Insulin Aspart (rDNA) is indicated to improve glycemic control in adults and children with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

Combination Insulin

30% Insulin Aspart and 70% Insulin Aspart Protamine (rDNA) is a human insulin analog suspension containing 30 % soluble Insulin Aspart and 70% Insulin Aspart Protamine crystals. This is a blood glucose lowering agent with an earlier onset and an intermediate duration of action. Insulin Aspart is homologous with regular human insulin with the exception of a single substitution of the proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing Saccharomyces cerevisiae (baker’s yeast).

Primary function of insulin, including Insulin Aspart, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, primarily by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.

The dosage of insulin aspart must be individualized.

Subcutaneous injection: insulin aspart should generally be given immediately (within 5-10 minutes) prior to the start of a meal.

Use in pumps: Change the insulin aspart in the reservoir at least every 6 days, change the infusion set, and the infusion set insertion site at least every 3 days. insulin aspart should not be mixed with other insulins or with a diluent when it is used in the pump.

Intravenous use: insulin aspart should be used at concentrations from 0.05 U/mL to 1.0 U/mL insulin aspart in infusion systems using polypropylene infusion bags. insulin aspart has been shown to be stable in infusion fluids such as 0.9% sodiumchloride.

Before going for administration of Biphasic Insulin Aspart (rDNA) please follow the below mentioned check list:

• Insulin syringe of the right size (100 units/ml)
• Prescribed type of insulin injection
• Check the expiry date on Biphasic Insulin Aspart (rDNA) vial
• Ensure that the flip off cap on the Biphasic Insulin Aspart (rDNA) vial is intact

After that follow the below mentioned instructions:

• Wash your hands carefully. Shake or roll the vial 10 times to completely Mix the insulin.
• lnspect the vial. Vial should appear white and cloudy after mixing.
• When using a new vial, flip off the plastic protective cap, but do not remove the stopper. The tip of the vial should be wiped with an alcohol swab.
• Draw air into the syringe equal to your insulin dose.
• Insert needle into vial through rubber top & push plunger to empty the air into the vial.
• Turn the bottle and syringe upside down. Hold the bottle and syringe firmly in one hand and shake gently. Make sure that the tip of the needle is in the liquid; withdraw the correct dose of insulin into the syringe.
• Before removing the needle from the vial, check the insulin syringe for air bubbles, which reduces the amount of insulin in it, if bubbles are present, hold the insulin straight up and tap its side until the bubbles float to the top. Push them out with the plunger and withdraw the correct dose again.
• Lightly pinch up the skin, holding the syringe like a pencil.
• Insert the needle into the skin & push the plunger slowly. Make sure that the needle is all the way in.
• Wait for 5 seconds & pull out the syringe. Do not rub the area.

Side effects of Insulin Aspart are hypoglycemia, lipodystrophy, weight gain, peripheral edema.

Biphasic Insulin Aspart (rDNA) is contraindicated

• During episodes of hypoglycemia
• In patients with hypersensitivity to Insulin Aspart or any of its excipients.

Dose adjustment and monitoring: Blood glucose should be monitored in all patients treated with insulin. Insulin regimens should be modified cautiously and only under medical supervision.

Renal or hepatic impairment: Reduction in the Insulin Aspart dose may require in these cases.

A number of substances affect glucose metabolism and may require dose adjustment and particularly close monitoring.

The following are examples that may increase the blood glucose lowering effect and susceptibility to hypoglycemia: oral anti-diabetic products, pramlintide and angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, propoxyphene, salicylates and sulfonamide antibiotics.

The following substances are examples that may reduce the blood glucose lowering effect: corticosteroids, niacin, danazol, diuretics, sympathomimetic agents, isoniazid, phenothiazine derivatives, somatropin, estrogens, progestogens, atypical antipsychotics and danazol. Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.

Pregnancy category B. Careful monitoring of glucose control is essential in such patients because insulin requirements change during different stages of pregnancy. Therefore female patients should be advised to tell their physician if they intend to become or if they become pregnant while taking insulin aspart

Lactation: It is unknown whether Insulin Aspart is excreted in human milk as occurs with human insulin. There are no adequate and well-controlled studies of the use of insulin aspart in lactating women. Lactating Women may require adjustments of their insulin doses.

Pediatric: Has not been studied in children with type 2 diabetes. Has not been studied in children with type 1 diabetes <2 years of age

Insulin Aspart overdose may result in hypoglycemia. Mild episodes of hypoglycemia can usually be treated with oral carbohydrates. Severe hypoglycemia may be treated with parenteral glucose or injections of glucagon. Adjustments in drug dosage, meal patterns, or exercise may be needed.

Store at 2°C to 8°C in a refrigerator. Do not freeze. In case of insulin for recent use need not be refrigerated, try to keep it in a cool place and keep away from heat and light. The insulin in use can be kept under the room temperature for a month.

Protamine Crystallised Insulin Aspart is an insulin analog indicated to improve glycemic control in patients with diabetes mellitus.

Rapid Acting Insulin

The primary activity of Insulin Aspart is the regulation of glucose metabolism. Insulin Aspart bind to the insulin receptors on muscle and fat cells and lower blood glucose by facilitating the cellular uptake of glucose and simultaneously inhibiting the output of glucose from the liver.

Insulin Aspart has a faster onset and a shorter duration of action than soluble human insulin. Due to the faster onset of action, Insulin Aspart should generally be given immediately before a meal. When necessary Insulin Aspart may be given soon after a meal.

Dosage of Insulin Aspart is individual and determined on the basis of the physician's advice in accordance with the needs of the patient. It should normally be used in combination with long-acting insulin given at least once a day.

The individual insulin requirement is usually between 0.5 and 1.0 IU/kg/day in adults and children over 2 years of age. In a meal-related treatment 50-70% of this requirement may be provided by Insulin Aspart and the remainder by long-acting insulin. Adjustment of dosage may also be necessary if patients undertake increased physical activity or change their usual diet. Exercise taken immediately after a meal may increase the risk of hypoglycaemia.

Subcutaneous Injection: Insulin Aspart should be administered by subcutaneous injection in the abdominal region, buttocks, thigh, or upper arm. Because Insulin Aspart has a more rapid onset and a shorter duration of activity than human regular insulin, it should be injected immediately (within 5-10 minutes) before a meal Continuous Subcutaneous Insulin Infusion (CSII) by External Pump Insulin Aspart can also be infused subcutaneously by an external insulin pump. The initial programming of the external insulin infusion pump should be based on the total daily insulin dose of the previous regimen. Approximately 50% of the total dose is usually given as meal-related boluses of Insulin Aspart and the remainder is given as a basal infusion. When used with an infusion pump Insulin Aspart should not be mixed with any other insulin.

Intravenous Use: Insulin Aspart can be administered intravenously under medical supervision for glycemic control with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia. For intravenous use, Insulin Aspart should be used at concentrations from 0.05 IU/mL to 1.0 IU/mL insulin aspart in infusion systems using polypropylene infusion bags. Insulin Aspart has been shown to be stable in infusion fluids such as 0.9% sodium chloride.

Instructions to be given to the patient before injecting this Insulin:

• According to the instruction given with ConviPen, insert the cartridge into the pen correctly & equip the needle
• Gently turn the pen upside down for 8-10 times until the insulin in the cartridge becomes uniformly mixed suspension
• Remove the needle cap, discharge air bubbles in the catridge
• Adjust the dosage button to get correct dose & inject to the specific site
• In order to avoid cross contamination, do not let the needle touch anything during the process of preparation.

Side effects of Insulin Aspart are hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus and rash.

Dose adjustment and monitoring: Blood glucose should be monitored in all patients treated with insulin. Insulin regimens should be modified cautiously and only under medical supervision

A number of drugs affect glucose metabolism and may require dose adjustment.

The following substances may reduce the Insulin as well as Insulin Aspart requirements: Oral anti-diabetic products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, propoxyphene, pentoxifylline, salicylates and sulfonamide antibiotics.

The following substances may increase the Insulin as well as Insulin Aspart requirements: Thiazides, glucocorticoids, thyroid hormones, beta-sympathomimetics, growth hormone and danazol. Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate or weaken the blood glucose lowering effect of insulin.

Pregnancy category B. There are no restrictions on treatment with Protamine Crystallised Insulin Aspart during lactation. Insulin treatment of the nursing mother should not affect the baby. However, dosage may need to be adjusted.

A specific overdose for insulin cannot be defined, however, hypoglycaemia may develop over sequential stages if too high doses relative to the patient’s requirement are administered. Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products. Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously. Glucose must also be given intravenously if the patient does not respond to glucagon within 10 to 15 minutes. Upon regaining consciousness administration of oral carbohydrate is recommended for the patient in order to prevent relapse.

Store at 2°C to 8°C in a refrigerator. Do not freeze. Protect from light.

Coagulation Factor VIIa is indicated in Bleeding episodes in patients with haemophilia, Bleeding episodes due to surgery or invasive procedures in patients with factor VII deficiency, Bleeding episodes due to surgery or invasive procedures in Glanzmann's thrombasthenia

Anti-fibrinolytic drugs

Recombinant factor VIIa is a biosynthetic preparation of activated factor VII produced by recombinant DNA technology. It is a vitamin K-dependent glycoprotein. It promotes haemostasis by activating the extrinsic pathway of the coagulation cascade. It replaces deficient activated coagulation factor VII, which complexes with tissue factor and may activate coagulation factor X and factor IX. Factor VIIa is given as the recombinant form, eptacog alfa (activated).

Bleeding episodes in patients with haemophilia:

• Adult: As activated eptacog alfa: Initially, 90 mcg/kg given via IV bolus over 2-5 min. Additional dose may be given as needed to achieve or maintain haemostasis, initially 2-3 hrly. May adjust dose or dosing interval according to response. May continue therapy for up to 3 wk or more in cases of serious bleeding episodes.

Bleeding episodes due to surgery or invasive procedures in patients with factor VII deficiency:

• Adult: As activated eptacog alfa: 15-30 mcg/kg 4-6 hrly via IV bolus over 2-5 min until haemostasis is achieved.

Bleeding episodes due to surgery or invasive procedures in Glanzmann's thrombasthenia:

• Adult: As activated eptacog alfa: 90 mcg/kg 2 hrly via IV bolus over 2-5 min, give at least 3 doses.

Nausea, vomiting, skin reactions, fever, headache and changes in BP. Rarely, anaphylaxis.

Hypersensitivity to recombinant coagulation factor VIIa or to mouse, hamster or bovine protein. Rare hereditary problems of fructose intolerance, glucose malabsorption or sucrose-isomaltase insufficiency.

Advanced atherosclerotic disease, crush injury, septicemia or disseminated intravascular coagulation. Patients w/ history of CHD, liver disease, undergoing major surgery, at risk of thromboembolic phenomena or disseminated intravascular coagulation. Remote possibility of hypersensitivity to mouse IgG, bovine IgG & other residual culture proteins. Monitor prothrombin time & factor VII coagulant activity in factor VII deficient patients. Pregnancy & lactation. Neonates.

Increased risk of thromboembolism with activated or non-activated prothrombin complex concentrate.

It is preferable to avoid use during pregnancy. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

It is unknown whether eptacog alfa is excreted in human breast milk. The excretion of eptacog alfa in milk has
not been studied in animals.

Add the recommended diluent (histidine), swirl gently until dissolved.

Store between 2-25° C prior to reconstitution. Do not freeze. Protect from light.

Used to temporarily numb the front surface of the eye so that the eye pressure can be measured or a foreign body removed.

Ocular perioperative drugs

Oxybuprocaine is a local anaesthetic. It may be less irritating than tetracaine, and the onset and duration of action are similar to tetracaine. Oxybuprocaine binds to sodium channel and reversibly stabilizes the neuronal membrane which decreases its permeability to sodium ions. Depolarization of the neuronal membrane is inhibited thereby blocking the initiation and conduction of nerve impulses.

Use as a 0.4% solution in short ophthalmic procedures. Instil 1 drop into the conjunctival sac to allow tonometry after 60 sec; a further drop after a 90 sec interval produces sufficiReduce systemic absorption by compressing the lacrimal sac at the medial canthus for a minute during and following instillation. Heart block; epilepsy, impaired cardiac conduction, myasthenia gravis; not to be applied to inflamed, infected tissues or damaged mucosa. Protect anaesthetised eye from dust and bacterial contamination; cornea may be damaged by prolonged application. Do not drive until normal vision restored.ent anaesthesia for the fitting of contact lenses; 3 drops at 90 sec intervals produces sufficient anaesthesia after 5 min for a foreign body to be removed from the corneal epithelium or for incision of a meibomian cyst through the conjunctiva.

Hypersensitivity reactions; transient stinging and blurring of vision; excitation of CNS; muscle twitching and tremors; convulsions.

Reduce systemic absorption by compressing the lacrimal sac at the medial canthus for a minute during and following instillation. Heart block; epilepsy, impaired cardiac conduction, myasthenia gravis; not to be applied to inflamed, infected tissues or damaged mucosa. Protect anaesthetised eye from dust and bacterial contamination; cornea may be damaged by prolonged application. Do not drive until normal vision restored.

Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

This tablet is indicated for-

• The management of moderate to moderately severe pain in adults.
• The short-term (five days or less) management of acute pain.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Paracetamol is a para aminophenol derivative, has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol is one of the most widely used, safest and fast acting analgesic. It is well tolerated and free from various side effects of aspirin.

Tramadol is a centrally acting synthetic opioid analgesic. Although its mode of action is not completely understood, from animal tests, at least two complementary mechanisms appear applicable: binding of parent and M₁ metabolite to μ-opioid receptors and weak inhibition of the reuptake of norepinephrine and serotonin. Opioid activity is due to both low affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M₁ to μ-opioid receptors. Tramadol has been shown to inhibit reuptake of norepinephrine and serotonin in vitro, as have some other opioid analgesics.These mechanisms may contribute independently to the overall analgesic profile of tramadol.

For the management of moderate to moderately severe pain: The recommended dose is 1 or 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.

In case of short-term (five days or less) management of acute pain: The recommended dose is 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.

This tablet can be administered without regard to food.

The following adverse reactions may happen to this therapy: asthenia, fatigue, hot flushes, dizziness, headache, tremor, abdominal pain, constipation, diarrhea, dyspepsia, dry mouth, nausea, vomiting, anorexia, anxiety, confusion, euphoria, insomnia, nervousness, somnolence pruritus, rash, increased sweating etc.

Tramadol & Paracetamol combination tablets should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, paracetamol, any other component of this product, or opioids. This is contraindicated in any situation where opioids are contraindicated.

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. This combination
preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. This combination preparation is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied.

pediatric use: The safety and effectiveness of this combination preparation have not been studied in the pediatric population.

Geriatric use:  In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function; of concomitant disease and multiple drug therapy.

Use in Renal Disease: This combination preparation has not been studied in patients with impaired renal
function. In patients with creatinine clearances of less than 30 ml/min, it is recommended that the dosing interval of this combination preparation be increased but not to exceed 2 tablets every 12 hours.

Use in Hepatic Disease: This combination preparation has not been studied in patients with impaired hepatic function. The use of this combination preparation in patients with hepatic impairment is not recommended.

Store in a cool and dry place. Do not freeze. Keep all medicines out of the reach of children.