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Tenoxicam is indicated for the symptomatic treatment of the following painful inflammatory and degenerative disorders of the musculoskeletal system:

• Rheumatoid arthritis.
• Osteoarthritis.
• Arthrosis.
• Ankylosing spondylitis.
• Extra-articular disorders, e.g. tendinitis, bursitis, periarthritis of the shoulders (shoulder-hand syndrome) or hips, strains, and sprains.
• Acute gout.

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Tenoxicam is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic properties and it also inhibits platelet aggregation. Tenoxicam inhibits prostaglandin biosynthesis. In-vitro tests of leukocyte peroxidase suggest that tenoxicam may act as a scavenger for active oxygen at the site of inflammation. Tenoxicam is a potent in-vitro inhibitor of human metalloproteinases (stromelysin and collagenase), which induce cartilage breakdown. These pharmacological effects explain, at least in part, the therapeutic benefit of Tenoxicam in the treatment of painful inflammatory and degenerative disorders of the musculoskeletal system. Tenoxicam showed no mutagenic, carcinogenic or teratogenic effects in animals. As with other prostaglandin inhibitors, renal and gastrointestinal effects, increased incidence of dystocia and delayed parturition were observed in animal safety studies.

Standard dosage: For all indications except acute gout, a daily dosage of 20 mg should be given at the same time of day.

In acute attacks of gout: The recommended dose for acute attacks of gout is 40 mg once daily for two days followed by 20 mg once daily for a further five days.

In the treatment of chronic disorders: The therapeutic effect of tenoxicam is evident early in treatment but there is a progressive increase in response over time. In chronic disorders, daily doses higher than 20 mg should be avoided since this would increase the frequency and intensity of unwanted reactions without significantly increasing efficacy. For patients needing long-term treatment, a reduction to a daily oral dose of 10 mg may be tried for maintenance.

Special dosage instructions: In principle, the above dosage recommendations also apply to elderly patients and to patients suffering from kidney or liver disease. Because of lack of clinical experience, no dosage recommendations have so far been established for children and adolescents.

The tablets should be taken with a glass of water. It is preferable to take this medicine during or immediately after a meal.

Based on clinical trials including large numbers of patients, Tenoxicam proved to be well tolerated in the recommended dose. Usually, the undesirable effects reported were mild and transient. In a small proportion of patients, the interruption of treatment due to undesirable effects was necessary. Local tolerance of Tenoxicam given parenterally was good. The following undesirable effects have been reported:

Frequency is greater than 1%-

• Gastrointestinal tract: gastric, epigastric and abdominal discomfort, dyspepsia, heartburn, nausea.
• Central nervous system: dizziness, headache.

Frequency less than 1%-

• Gastrointestinal tract: constipation, diarrhea, stomatitis, gastritis, vomiting, ulcers, Gl-bleeding including hematemesis and melena.
• Central nervous system: fatigue, sleep disturbances, appetite loss, dry mouth, vertigo.
• Skin: itching (also in the anal region after rectal administration), erythema, exanthema, rash, urticaria.
• Urinary tract and kidneys: increase in BUN or creatinine, edema.
• Liver and biliary tract: increased liver enzyme activity.
• Cardiovascular system: palpitations.

Isolated cases (frequency less than 0.01%)-

• Gastrointestinal tract: Gl-perforation.
• Central nervous system: visual disturbances.
• Skin: Stevens-Johnson and Lyell's syndrome, photosensitivity reaction, vasculitis.
• Blood: anemia, agranulocytosis, leukopenia, thrombocytopenia.
• Hypersensitivity reactions: dyspnea, asthma, anaphylaxis, angioedema.
• Cardiovascular system: elevated blood pressure, mainly in patients treated with cardiovascular drugs.
• Liver/Biliary tract: hepatitis.

Tenoxicam must not be administered to patients:

• known to be hypersensitive to the drug;
• in whom salicylates or other non-steroidal anti-inflammatory drugs (NSAIDs) induce symptoms of asthma, rhinitis, or urticaria;
• suffering or having suffered from the disease of the upper gastrointestinal tract, such as gastritis, gastric and duodenal ulcer.

NSAIDs inhibit renal prostaglandin synthesis and consequently may have an undesirable effect on renal hemodynamics and on salt and water balance. It is necessary to adequately monitor the patient with a special emphasis on cardiac and renal function (BUN, creatinine, development of edema, weight gain, etc.) when giving Tenoxicam to patients with conditions that could increase their risk of developing renal failure, such as pre-existing renal disease, impaired renal function in diabetics, hepatic cirrhosis, congestive heart failure, volume depletion or concomitant treatment with potentially nephrotoxic drugs, diuretics and corticosteroids. Tenoxicam inhibits platelet aggregation and may affect hemostasis. Tenoxicam has no significant influence on blood coagulation factors, coagulation time, prothrombin time or activated thromboplastin time. Patients having coagulation disorders or receiving drug therapy that interferes with hemostasis should, however, be carefully observed when Tenoxicam is administered. Any patient being treated with Tenoxicam who presents with symptoms of gastrointestinal disease should be closely monitored. If peptic ulceration or gastrointestinal bleeding occurs, Tenoxicam should be immediately withdrawn. If severe skin reactions (e.g. Lyell's or Stevens-Johnson syndrome) occur, the treatment should be discontinued immediately. Adverse eye findings have been reported with Tenoxicam. Thus ophthalmic evaluation is recommended for patients who develop visual disturbances. Because of the high plasma protein binding of tenoxicam, caution is required when plasma albumin levels are markedly reduced. In common with anti-inflammatory drugs, Tenoxicam may mask the usual signs of infection. Tenoxicam Tablets should not be given to patients who either dislike or do not tolerate milk products.

As in the case of other NSAIDs, salicylate displaces tenoxicam from protein-binding sites and increases clearance and volume of distribution of tenoxicam. Concurrent treatment with salicylate or other NSAIDs should be avoided because of increased risk of gastrointestinal undesirable reactions. The co-administration of some NSAIDs and methotrexate has been associated with reduced renal tubular secretion of methotrexate, higher plasma concentrations of methotrexate, and severe methotrexate toxicity. Therefore, caution should be exercised when Tenoxicam is administered concurrently with methotrexate. No clinically relevant interaction was found in the small number of patients receiving concomitant treatment with gold, penicillamine or probenecid. As Tenoxicam may decrease the renal clearance of lithium, their concomitant administration may lead to increased plasma levels and toxicity of lithium. The plasma levels of lithium should be closely monitored. As with NSAIDs in general, Tenoxicam should not be administered concurrently with K-sparing diuretics. There is a known interaction between these two classes of compounds, which may cause hyperkalemia and renal failure. No clinically significant interaction between Tenoxicam and furosemide was noted, but Tenoxicam attenuates the blood pressure-lowering effect of hydrochlorothiazide. As known from other NSAIDs, Tenoxicam might attenuate the antihypertensive effects of alpha-adrenergic blockers and ACE-inhibitors. No interactions have been reported between NSAIDs and centrally-acting alpha agonists or calcium channel blockers. There was no clinically relevant interaction when Tenoxicam was administered together with atenolol. During clinical trials no interaction was reported for patients treated concomitantly with digitalis products. Thus concurrent dosing of Tenoxicam and digoxin appears to be without major risk. No interaction has been found with concomitantly administered antacids, cimetidine, warfarin and phenprocoumon at the recommended dosages. The clinical effect of oral antidiabetic drugs (glibornuride, glibenclamide, tolbutamide) was likewise not modified by Tenoxicam. Nevertheless, careful monitoring is recommended when patients concomitantly receive anticoagulants or oral antidiabetic drugs. No clinically relevant interaction has been found between Tenoxicam and low molecular weight heparin.

NSAIDs have an inhibitory effect on prostaglandin synthesis and, when given during late pregnancy, may cause the closure of the fetal ductus arteriosus, prolong labor and delay parturition. Treatment during the third trimester of pregnancy should be avoided. Based on findings from single-dose administration, a very small amount (approximately 0.2%) of tenoxicam passes into breast milk. There is no evidence of adverse reactions in breast-fed infants of mothers taking Tenoxicam. Nevertheless, infants should be weaned or the drug discontinued.

Use in Children & adolescent: Tenoxicam is not recommended for use in patients under 16 years of age, as the dose and indications in this population have not been established.

Effects on ability to drive and use machines: Patients experiencing adverse events that might affect driving or using machines, such as vertigo, dizziness or visual disturbances should refrain from driving a car or using machines.

Although there is no experience of acute overdosage with Tenoxicam, it may be expected that the signs and symptoms mentioned under Undesirable effects would be more pronounced. Overdose should be countered by conventional measures to reduce absorption (e.g. gastrolavage and charcoal) and speed up elimination (e.g. cholestyramine).

Do not store above 30°C, protect from light & moisture. Keep out of the reach of children.

Third generation Cephalosporins

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

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

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

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

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

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

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

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

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

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

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

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

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

Third generation Cephalosporins

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

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

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

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

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

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

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

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

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

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

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

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

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

Third generation Cephalosporins

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

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

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

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

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

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

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

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

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

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

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

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

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

Other antibiotic

After conversion to its active form by phosphatases, tedizolid exerts its antibacterial activity through inhibition of protein synthesis by binding to the 50S ribosomal subunit of susceptible Gram-positive bacteria. Cross-resistance between other non-oxazolidinone antibacterial drugs is unlikely as it inhibits bacterial protein synthesis through a different mechanism.

Acute Bacterial Skin and Skin Structure Infection (ABSSSI):

• Intravenous: 200 mg Once daily 1 hour (Infusion Time) for 6 days
• Oral: 200 mg Once daily for 6 days

No dose adjustment is necessary when changing from intravenous to oral Tedizolid. If patients miss a dose, they should take it as soon as possible anytime up to 8 hours prior to their next scheduled dose. If less than 8 hours remain before the next dose, wait until their next scheduled dose.

The most common adverse reactions (>2%) are nausea, headache, diarrhea, vomiting, and dizziness

None

Patients with neutropenia: The safety and efficacy of Tedizolid in patients with neutropenia (neutrophil counts <1000 cells/mm3) have not been adequately evaluated. In an animal model of infection, the antibacterial activity of Tedizolid was reduced in the absence of granulocytes. Consider alternative therapies in neutropenic patients.

Clostridium difficile-associated diarrhea: Evaluate if diarrhea occurs.

Tedizolid (when administered orally) can increase the plasma concentrations of orally administered Breast Cancer Resistance Protein BCRP substrates. Monitor for adverse reactions related to the concomitant BCRP substrates if coadministration cannot be avoided

Pregnancy category C. There are no adequate and well-controlled studies of Tedizolid in pregnant women. Tedizolid should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: Tedizolid is excreted in the breast milk of rats. It is not known whether tedizolid is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tedizolid is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in pediatric patients below the age of 18 have not been established.

Geriatric Use: Clinical studies of Tedizolid did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. No overall differences in pharmacokinetics were observed between elderly subjects and younger subjects

In the event of overdosage, Tedizolid should be discontinued and general supportive treatment given. Hemodialysis does not result in meaningful removal of tedizolid from systemic circulation

Tablets and injection should be stored at 20°C to 25°C

Other antibiotic

After conversion to its active form by phosphatases, tedizolid exerts its antibacterial activity through inhibition of protein synthesis by binding to the 50S ribosomal subunit of susceptible Gram-positive bacteria. Cross-resistance between other non-oxazolidinone antibacterial drugs is unlikely as it inhibits bacterial protein synthesis through a different mechanism.

Acute Bacterial Skin and Skin Structure Infection (ABSSSI):

• Intravenous: 200 mg Once daily 1 hour (Infusion Time) for 6 days
• Oral: 200 mg Once daily for 6 days

No dose adjustment is necessary when changing from intravenous to oral Tedizolid. If patients miss a dose, they should take it as soon as possible anytime up to 8 hours prior to their next scheduled dose. If less than 8 hours remain before the next dose, wait until their next scheduled dose.

The most common adverse reactions (>2%) are nausea, headache, diarrhea, vomiting, and dizziness

None

Patients with neutropenia: The safety and efficacy of Tedizolid in patients with neutropenia (neutrophil counts <1000 cells/mm3) have not been adequately evaluated. In an animal model of infection, the antibacterial activity of Tedizolid was reduced in the absence of granulocytes. Consider alternative therapies in neutropenic patients.

Clostridium difficile-associated diarrhea: Evaluate if diarrhea occurs.

Tedizolid (when administered orally) can increase the plasma concentrations of orally administered Breast Cancer Resistance Protein BCRP substrates. Monitor for adverse reactions related to the concomitant BCRP substrates if coadministration cannot be avoided

Pregnancy category C. There are no adequate and well-controlled studies of Tedizolid in pregnant women. Tedizolid should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: Tedizolid is excreted in the breast milk of rats. It is not known whether tedizolid is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tedizolid is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in pediatric patients below the age of 18 have not been established.

Geriatric Use: Clinical studies of Tedizolid did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. No overall differences in pharmacokinetics were observed between elderly subjects and younger subjects

In the event of overdosage, Tedizolid should be discontinued and general supportive treatment given. Hemodialysis does not result in meaningful removal of tedizolid from systemic circulation

Tablets and injection should be stored at 20°C to 25°C

Other antibiotic

After conversion to its active form by phosphatases, tedizolid exerts its antibacterial activity through inhibition of protein synthesis by binding to the 50S ribosomal subunit of susceptible Gram-positive bacteria. Cross-resistance between other non-oxazolidinone antibacterial drugs is unlikely as it inhibits bacterial protein synthesis through a different mechanism.

Acute Bacterial Skin and Skin Structure Infection (ABSSSI):

• Intravenous: 200 mg Once daily 1 hour (Infusion Time) for 6 days
• Oral: 200 mg Once daily for 6 days

No dose adjustment is necessary when changing from intravenous to oral Tedizolid. If patients miss a dose, they should take it as soon as possible anytime up to 8 hours prior to their next scheduled dose. If less than 8 hours remain before the next dose, wait until their next scheduled dose.

The most common adverse reactions (>2%) are nausea, headache, diarrhea, vomiting, and dizziness

None

Patients with neutropenia: The safety and efficacy of Tedizolid in patients with neutropenia (neutrophil counts <1000 cells/mm3) have not been adequately evaluated. In an animal model of infection, the antibacterial activity of Tedizolid was reduced in the absence of granulocytes. Consider alternative therapies in neutropenic patients.

Clostridium difficile-associated diarrhea: Evaluate if diarrhea occurs.

Tedizolid (when administered orally) can increase the plasma concentrations of orally administered Breast Cancer Resistance Protein BCRP substrates. Monitor for adverse reactions related to the concomitant BCRP substrates if coadministration cannot be avoided

Pregnancy category C. There are no adequate and well-controlled studies of Tedizolid in pregnant women. Tedizolid should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: Tedizolid is excreted in the breast milk of rats. It is not known whether tedizolid is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tedizolid is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in pediatric patients below the age of 18 have not been established.

Geriatric Use: Clinical studies of Tedizolid did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. No overall differences in pharmacokinetics were observed between elderly subjects and younger subjects

In the event of overdosage, Tedizolid should be discontinued and general supportive treatment given. Hemodialysis does not result in meaningful removal of tedizolid from systemic circulation

Tablets and injection should be stored at 20°C to 25°C

This Sterile Eye Drops is indicated for steroid responsive ocular inflammatory conditions with involvement of bacteria like blepharitis, scleritis, episcleritis, iritis, cyclitis, iridocyclitis, choroiditis, optic neuritis and chronic anterior uveitis, disciform and interstitial keratitis, allergic corneal marginal ulcers, corneal injury from chemical radiation or thermal burns.

Ophthalmic steroid - antibiotic combined preparations

Dexamethasone is a synthetic glucocorticoid which decreases inflammation by inhibiting the migration of leukocytes and reversal of increased capillary permeability. It suppresses normal immune response.

Gatifloxacin inhibits bacterial DNA gyrase and Topoisomerase IV, the enzymes responsible for replication, transcription and repair of bacterial DNA.

Instill 1-2 drops into the conjunctival sac 3 to 4 times daily.

Mild burning, chemosis, redness may occur.

This is contraindicated in epithelial herpes simplex keratitis (Dendritic keratitis), vaccinia, varicella, and in many other viral diseases of the conjunctiva and cornea. It is also contraindicated in mycobacterial infection of the eye, fungal diseases of ocular structures and in individuals hypersensitive to any of the components of the medication.

For ophthalmic use only. If the product is used for 10 days or more, intraocular pressure should be monitored routinely.

Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Gatifloxacin + Dexamethasone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use in lactation: Caution should be exercised when Gatifloxacin + Dexamethasone is administered to a nursing mother.

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

Overdose through local administration is not known. In case of accidental oral intake, specific measures to reduce resorption should be taken. There is no specific antidote.

Store at room temperature. Protect from light. Close the bottle immediately after use. Do not use for longer than one month after opening the bottle.

Third generation Cephalosporins

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

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

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

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

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

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

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

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

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

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

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

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

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

Third generation Cephalosporins

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

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

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

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

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

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

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

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

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

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

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

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

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

Third generation Cephalosporins

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

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

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

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

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

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

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

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

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

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

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

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

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

Third generation Cephalosporins

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

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

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

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

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

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

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

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

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

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

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

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

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

Vitamin-B preparations

Thiamine, in the form of thiamine pyrophosphate, is the coenzyme for decarboxylation of α-ketoglutaric acid. Thiamine deficiency affects the peripheral nervous system, the gastrointestinal tract, and the cardiovascular system. This vitamin is necessary for the optimal growth of infants and children. Thiamine is not stored in the body, and is regularly lost from tissues during short periods of deficiency. In order to maintain normal health, an adequate amount of thiamine is required every day. Deficiency of thiamine leads to fatigue, anorexia, gastrointestinal disturbance, tachycardia, irritability and neurological symptoms. Beriberi, a disease due to vitamin B1 deficiency, is common in alcoholics, in pregnant women receiving an inadequate diet, and in people with malabsorption syndrome, prolonged diarrhoea and hepatic disease.

Thiamine is well absorbed from the gastrointestinal tract and widely distributed throughout the body. Thiamine is rapidly absorbed from the upper small intestine. Thiamine is not stored in the body to any appreciable extent. Excess ingested thiamine appears in urine as intact thiamine or as pyrimidine, which arises from degradation of the thiamine molecule. The plasma half life of thiamine is 24 hours.

Prophylaxis: 3 to 10 mg daily.
Mild chronic deficiency: 10 to 25 mg daily.
Severe deficiency: 200 to 300 mg daily.

Vitamin B1 does not have adverse effects when given orally, but in a few fatal cases anaphylactic reactions have occurred after intravenous administration of large doses (400 mg) in sensitive patients, especially children, and in one case following an intramuscular dose of 125 mg. The risk of such reactions increases with repeated administration of the drug by parenteral route. Transient mild soreness may occur at the site of intramuscular administration

There is no absolute contraindication but the risk of anaphylaxis is increased by repeated parenteral administration. Mild allergic phenomena, such as sneezing or mild asthma are warning signs that further may give rise to anaphylactic shock. To avoid this possibility it is advisable to start a second course of injection with a dose considerably lower than that previously used. Because of the above, vitamin B1 injection should not be given intravenously except in the case of comatose patients. Once thiamine deficiency is corrected there is no need for parenteral administration or for the administration of amounts in excess of daily requirement.

No hazardous drug interactions have been reported. Vitamin B1 acts synergistically with other vitamins of the B-complex group and its potential for causing adverse effects is considerably reduced.

The drug may be given safely to neonates, children, pregnant and lactating women and elderly patients.

Thiamine injection should be protected from light and moisture.

Chlorthalidone is indicated in the management of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis and corticosteroid and estrogen therapy.

Thiazide diuretics & related drugs

Chlorthalidone is a thiazide-type Diuretic- Antihypertensive, used for the treatment of hypertension. It may be used alone or in association with other antihypertensive agents. Chlortalidone is also indicated for adjunctive therapy of edema associated with: renal disease; congestive heart failure of mild to moderate degree (functional class II, Ill), when glomerular filtration rate is greater than 30 ml/min; ascites due to cirrhosis of the liver in stable patients; estrogen therapy; corticosteroid therapy.

Chlorthalidone inhibits the reabsorption of sodium and chloride in the distal renal tubule thus promoting water loss. The higher urine volume increases potassium loss. Little information is available on the absorption of the drug. Its long elimination half-life and clinical experience place it as a long-acting thiazide derivative. The longer-acting agents appear to cause increased potassium loss.

Although a mild diuretic, its combination with loop diuretics is particularly potent because the latter presents much more sodium chloride to the distal tubule.

The blood pressure lowering effects are initially due to volume reduction but the persisting effect includes other undetermined mechanisms that reduce peripheral resistance. A high salt intake reverses its antihypertensive effect.

The major portion of an absorbed dose of Chlorthalidone is excreted by the kidneys with an elimination half life averaging 50 hours. Metabolism and hepatic excretion into the bile constitute a minor way of elimination. Within 120 hours, about 70% of the dose is excreted in the urine and in the feces, mainly in an unchanged form.

Therapy should be initiated with the lowest possible dose, and be titrated thereafter to gain maximum therapeutic benefit while keeping side effects to a minimum (e.g. determine the minimum effective maintenance dose for each patient). A single dose daily or every other day is given in the morning with food is recommended.

Hypertension: Usual adult dose is 25 to 50 mg daily. The clinically useful dosage range is 12.5 to 50 mg daily. Doses greater than 50 mg per day increase metabolic complications and are rarely of therapeutic benefit. For a given dose, the full effect is reached after 3 to 4 weeks. If the decrease in blood pressure obtained using doses of 25 or 50 mg/day proves inadequate, combined treatment with other antihypertensive drugs (such as beta-blockers and ACE inhibitors) is recommended. When adding an ACE inhibitor, Chlorthalidone is to be reduced or discontinued.

Edema of Specific Origin: The lowest effective dose is to be identified by titration. Maintenance doses should not exceed 50 mg/day and should be administered over limited periods only. The dosage should be individually adapted to the clinical picture and patient response. For long-term therapy, the lowest possible dosage sufficient to maintain an optimal effect should be employed; this applies particularly to elderly patients.

The therapeutic effect of Chlorthalidone occurs even without salt restriction and is well sustained during continued use.

The elderly: This is a suitable drug for treating hypertension in the elderly, in particular systolic hypertension. Dose of 50 mg daily, or less, should be used to avoid hypovolemia and hypokalemia.

Electrolytes and Metabolic Disorders: Frequent: mainly at higher doses, hypokalemia, hyperuricemia and rise in blood lipids. Occasional: hyponatremia, hypomagnesemia and hyperglycemia. Rare: hypercalcemia, glycosuria, worsening of diabetic metabolic state and gout.

Isolated cases: hypochloremic alkalosis.

Dermatology: Occasional: urticaria and other forms of skin rash. Rare: photosensitization.

Liver: Rare: Intrahepatic cholestasis or jaundice.

Cardiovascular: Occasional: postural hypotension, which may be aggravated by alcohol, anesthetics or sedatives. Rare: cardiac arrhythmias.

CNS: Occasional: dizziness, slow mentation and decreased reaction time.

Anuria, severe renal failure (creatinine clearance lower than 30 mL/min), severe hepatic failure, refractory hypokalemia or conditions involving enhanced potassium loss, hyponatremia, hypercalcemia, symptomatic hyperuricemia (history of gout or uric acid calculi). Hypersensitivity or suspected hypersensitivity to Chlorthalidone and other sulfonamide derivatives or their excipients.

Should be used with caution in patients with renal disease or with impaired hepatic function. Because of the possibility of progression of renal damage, periodic determination of the BUN and serum creatinine are indicated. Should there be an elevation of either parameter, treatment should be discontinued. Like thiazides, Chlorthalidone may lose its diuretic efficacy when glomerular filtration rate drops below 30 mL/min, a point at which treatment with loop diuretics may be more appropriate.

Electrolytes: As with thiazide diuretics, kaluresis induced by Chlorthalidone is dose dependent, and there is inter-individual variability in magnitude. With 25 mg/day, serum potassium concentration decreases average 0.5 mmol/L. If chronic treatment is contemplated, serum potassium concentrations should be determined initially, and then 3 to 4 weeks later. If thereafter, potassium balance is not disturbed further, concentrations should be assessed every 4 to 6 months. Conditions that may alter potassium balance include: vomiting, diarrhea, malnutrition, change in renal function (e.g. nephrosis), liver cirrhosis, hyperaldosteronism, or concomitant use of corticosteroids or ACTH. Titrated co-administration of an oral potassium salt (e.g. KCI) may be considered in patients: receiving digitalis; exhibiting signs of coronary heart disease, unless they are also receiving an ACE inhibitor; on high doses of a beta-adrenergic agonist; whose plasma potassium concentrations are less than 3.0 mmol/L.

Renal impairment: Chlorthalidone dosage should be reduced in moderate renal failure - every 24 or 48 h - and should not be used in advanced renal failure.

Liver disease: There is a risk of precipitating hepatic encephalopathy in patients with liver cirrhosis and ascites.

Use in pregnancy: It is better to avoid Chlorthalidone as it crosses the placenta.

Use in Lactation: In lactating mother, significant amount of Chlorthalidone enter breast milk; like other long-acting thiazides, it can suppress lactation. Chlorthalidone should not be prescribed for lactating mother.

Other interactions: Patients with Special Diseases and Conditions in patients with impaired hepatic function or progressive liver disease, caution should be exercised since even minor alterations in fluid and electrolyte balance or of serum ammonia may precipitate hepatic coma. Treatment with thiazide diuretics should be initiated cautiously in postsympathectomy patients since the antihypertensive effects may be enhanced. A cautious dosage schedule should be adopted in patients with severe coronary or cerebral ateriosderosis.

Drug Interactions-
Antihypertensive Agents: Diuretics potentiate the action of curare derivatives and antihypertensive agents (e.g. guanethidine, methyldopa, beta-blockers, vasodilators, calcium antagonists, ACE inhibitors).

Digitalis: Thiazide-induced hypokalemia or hypomagnesemia may increase the likelihood of digitalis-induced cardiac arrhythmias (see also Precautions).

Corticosteroids: The hypokalemic effects of diuretics may be increased by corticosteroids, ACTH and amphotericin. Insulin and Oral Antidiabetic Agents: It may be necessary to adjust the dosage of insulin or oral antidiabetic agents in response to changes in glucose tolerance that Chlorthalidone may produce.

NSAIDs: Concomitant administration of certain NSAIDs (e.g. indomethacin) may weaken the diuretic and antihypertensive activity of thiazides, and there have been isolated reports of a deterioration of renal function in predisposed patients.

Curare Derivatives and Ganglionic Blocking Agents: Thiazides may increase responsiveness to curare derivatives and ganglionic blocking agents.

Allopurinol: Co-administration of thiazide diuretics may increase the incidence of hypersensitivity reactions to allopurinol.

Amantadine: Co-administration of thiazide diuretics may increase the risk of adverse effects from amantadine.

Antineoplastic Agents (e.g. cyclophosphamide, methotrexate): Concomitant use of thiazide diuretics may reduce renal excretion of cytotoxic agents and enhance the myelo suppressive effects. Anticholinergics (e.g. atropine, biperiden): The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents, apparently due to a decrease in gastrointestinal motility and rate of gastric emptying.

Cholestyramine: Absorption of thiazide diuretics is decreased by cholestyramine, therefore a decrease in pharmacological effect may be expected.

Vitamin D: Concomitant use of thiazide diuretics may decrease urinary excretion of calcium, and co-administration of Vitamin D may potentiate the increase in serum calcium.

Cyclosporin: Concomitant treatment with diuretics may increase the risk of hyperuricemia and gout-type complications.

Calcium Salts: Concomitant use of thiazide-type diuretics may cause hypercalcemia by increasing tubular calcium reabsorption.

Diazoxide: Thiazide diuretics may enhance the hyperglycemic effect of diazoxide.

Pregnancy: Chlorthalidone, like other diuretics, can cause placental hypoperfusion. Since they do not prevent or alter the course of EPH (edema, proteinuria, hypertension) preeclampsia, these drugs must not be used to treat hypertension in pregnant women. The use of Chlorthalidone for other indications (e.g. heart disease) in pregnancy should be avoided, particularly in the first trimester, unless the potential benefits outweigh the possible risks (e.g. when there are no safer altenatives).

Lactation: Chlorthalidone appears in breast milk, attaining concentrations of approximately 4% of maternal blood levels. Therefore use in nursing mothers should be avoided.

Symptoms of acute overdosage include nausea, weakness, dizziness, and disturbances of electrolyte balance. The oral LD 50 of the drug in the mouse and the rat is more than 25,000 mg/kg body weight. The minimum lethal dose (MLD) in humans has not been established. There is no specific antidote, but gastric lavage is recommended, followed by supportive treatment. Where necessary, this may include intravenous dextrose-saline with potassium, administered with caution.

Store in a cool and dry place, protected from light.

Chlorthalidone is indicated in the management of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis and corticosteroid and estrogen therapy.

Thiazide diuretics & related drugs

Chlorthalidone is a thiazide-type Diuretic- Antihypertensive, used for the treatment of hypertension. It may be used alone or in association with other antihypertensive agents. Chlortalidone is also indicated for adjunctive therapy of edema associated with: renal disease; congestive heart failure of mild to moderate degree (functional class II, Ill), when glomerular filtration rate is greater than 30 ml/min; ascites due to cirrhosis of the liver in stable patients; estrogen therapy; corticosteroid therapy.

Chlorthalidone inhibits the reabsorption of sodium and chloride in the distal renal tubule thus promoting water loss. The higher urine volume increases potassium loss. Little information is available on the absorption of the drug. Its long elimination half-life and clinical experience place it as a long-acting thiazide derivative. The longer-acting agents appear to cause increased potassium loss.

Although a mild diuretic, its combination with loop diuretics is particularly potent because the latter presents much more sodium chloride to the distal tubule.

The blood pressure lowering effects are initially due to volume reduction but the persisting effect includes other undetermined mechanisms that reduce peripheral resistance. A high salt intake reverses its antihypertensive effect.

The major portion of an absorbed dose of Chlorthalidone is excreted by the kidneys with an elimination half life averaging 50 hours. Metabolism and hepatic excretion into the bile constitute a minor way of elimination. Within 120 hours, about 70% of the dose is excreted in the urine and in the feces, mainly in an unchanged form.

Therapy should be initiated with the lowest possible dose, and be titrated thereafter to gain maximum therapeutic benefit while keeping side effects to a minimum (e.g. determine the minimum effective maintenance dose for each patient). A single dose daily or every other day is given in the morning with food is recommended.

Hypertension: Usual adult dose is 25 to 50 mg daily. The clinically useful dosage range is 12.5 to 50 mg daily. Doses greater than 50 mg per day increase metabolic complications and are rarely of therapeutic benefit. For a given dose, the full effect is reached after 3 to 4 weeks. If the decrease in blood pressure obtained using doses of 25 or 50 mg/day proves inadequate, combined treatment with other antihypertensive drugs (such as beta-blockers and ACE inhibitors) is recommended. When adding an ACE inhibitor, Chlorthalidone is to be reduced or discontinued.

Edema of Specific Origin: The lowest effective dose is to be identified by titration. Maintenance doses should not exceed 50 mg/day and should be administered over limited periods only. The dosage should be individually adapted to the clinical picture and patient response. For long-term therapy, the lowest possible dosage sufficient to maintain an optimal effect should be employed; this applies particularly to elderly patients.

The therapeutic effect of Chlorthalidone occurs even without salt restriction and is well sustained during continued use.

The elderly: This is a suitable drug for treating hypertension in the elderly, in particular systolic hypertension. Dose of 50 mg daily, or less, should be used to avoid hypovolemia and hypokalemia.

Electrolytes and Metabolic Disorders: Frequent: mainly at higher doses, hypokalemia, hyperuricemia and rise in blood lipids. Occasional: hyponatremia, hypomagnesemia and hyperglycemia. Rare: hypercalcemia, glycosuria, worsening of diabetic metabolic state and gout.

Isolated cases: hypochloremic alkalosis.

Dermatology: Occasional: urticaria and other forms of skin rash. Rare: photosensitization.

Liver: Rare: Intrahepatic cholestasis or jaundice.

Cardiovascular: Occasional: postural hypotension, which may be aggravated by alcohol, anesthetics or sedatives. Rare: cardiac arrhythmias.

CNS: Occasional: dizziness, slow mentation and decreased reaction time.

Anuria, severe renal failure (creatinine clearance lower than 30 mL/min), severe hepatic failure, refractory hypokalemia or conditions involving enhanced potassium loss, hyponatremia, hypercalcemia, symptomatic hyperuricemia (history of gout or uric acid calculi). Hypersensitivity or suspected hypersensitivity to Chlorthalidone and other sulfonamide derivatives or their excipients.

Should be used with caution in patients with renal disease or with impaired hepatic function. Because of the possibility of progression of renal damage, periodic determination of the BUN and serum creatinine are indicated. Should there be an elevation of either parameter, treatment should be discontinued. Like thiazides, Chlorthalidone may lose its diuretic efficacy when glomerular filtration rate drops below 30 mL/min, a point at which treatment with loop diuretics may be more appropriate.

Electrolytes: As with thiazide diuretics, kaluresis induced by Chlorthalidone is dose dependent, and there is inter-individual variability in magnitude. With 25 mg/day, serum potassium concentration decreases average 0.5 mmol/L. If chronic treatment is contemplated, serum potassium concentrations should be determined initially, and then 3 to 4 weeks later. If thereafter, potassium balance is not disturbed further, concentrations should be assessed every 4 to 6 months. Conditions that may alter potassium balance include: vomiting, diarrhea, malnutrition, change in renal function (e.g. nephrosis), liver cirrhosis, hyperaldosteronism, or concomitant use of corticosteroids or ACTH. Titrated co-administration of an oral potassium salt (e.g. KCI) may be considered in patients: receiving digitalis; exhibiting signs of coronary heart disease, unless they are also receiving an ACE inhibitor; on high doses of a beta-adrenergic agonist; whose plasma potassium concentrations are less than 3.0 mmol/L.

Renal impairment: Chlorthalidone dosage should be reduced in moderate renal failure - every 24 or 48 h - and should not be used in advanced renal failure.

Liver disease: There is a risk of precipitating hepatic encephalopathy in patients with liver cirrhosis and ascites.

Use in pregnancy: It is better to avoid Chlorthalidone as it crosses the placenta.

Use in Lactation: In lactating mother, significant amount of Chlorthalidone enter breast milk; like other long-acting thiazides, it can suppress lactation. Chlorthalidone should not be prescribed for lactating mother.

Other interactions: Patients with Special Diseases and Conditions in patients with impaired hepatic function or progressive liver disease, caution should be exercised since even minor alterations in fluid and electrolyte balance or of serum ammonia may precipitate hepatic coma. Treatment with thiazide diuretics should be initiated cautiously in postsympathectomy patients since the antihypertensive effects may be enhanced. A cautious dosage schedule should be adopted in patients with severe coronary or cerebral ateriosderosis.

Drug Interactions-
Antihypertensive Agents: Diuretics potentiate the action of curare derivatives and antihypertensive agents (e.g. guanethidine, methyldopa, beta-blockers, vasodilators, calcium antagonists, ACE inhibitors).

Digitalis: Thiazide-induced hypokalemia or hypomagnesemia may increase the likelihood of digitalis-induced cardiac arrhythmias (see also Precautions).

Corticosteroids: The hypokalemic effects of diuretics may be increased by corticosteroids, ACTH and amphotericin. Insulin and Oral Antidiabetic Agents: It may be necessary to adjust the dosage of insulin or oral antidiabetic agents in response to changes in glucose tolerance that Chlorthalidone may produce.

NSAIDs: Concomitant administration of certain NSAIDs (e.g. indomethacin) may weaken the diuretic and antihypertensive activity of thiazides, and there have been isolated reports of a deterioration of renal function in predisposed patients.

Curare Derivatives and Ganglionic Blocking Agents: Thiazides may increase responsiveness to curare derivatives and ganglionic blocking agents.

Allopurinol: Co-administration of thiazide diuretics may increase the incidence of hypersensitivity reactions to allopurinol.

Amantadine: Co-administration of thiazide diuretics may increase the risk of adverse effects from amantadine.

Antineoplastic Agents (e.g. cyclophosphamide, methotrexate): Concomitant use of thiazide diuretics may reduce renal excretion of cytotoxic agents and enhance the myelo suppressive effects. Anticholinergics (e.g. atropine, biperiden): The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents, apparently due to a decrease in gastrointestinal motility and rate of gastric emptying.

Cholestyramine: Absorption of thiazide diuretics is decreased by cholestyramine, therefore a decrease in pharmacological effect may be expected.

Vitamin D: Concomitant use of thiazide diuretics may decrease urinary excretion of calcium, and co-administration of Vitamin D may potentiate the increase in serum calcium.

Cyclosporin: Concomitant treatment with diuretics may increase the risk of hyperuricemia and gout-type complications.

Calcium Salts: Concomitant use of thiazide-type diuretics may cause hypercalcemia by increasing tubular calcium reabsorption.

Diazoxide: Thiazide diuretics may enhance the hyperglycemic effect of diazoxide.

Pregnancy: Chlorthalidone, like other diuretics, can cause placental hypoperfusion. Since they do not prevent or alter the course of EPH (edema, proteinuria, hypertension) preeclampsia, these drugs must not be used to treat hypertension in pregnant women. The use of Chlorthalidone for other indications (e.g. heart disease) in pregnancy should be avoided, particularly in the first trimester, unless the potential benefits outweigh the possible risks (e.g. when there are no safer altenatives).

Lactation: Chlorthalidone appears in breast milk, attaining concentrations of approximately 4% of maternal blood levels. Therefore use in nursing mothers should be avoided.

Symptoms of acute overdosage include nausea, weakness, dizziness, and disturbances of electrolyte balance. The oral LD 50 of the drug in the mouse and the rat is more than 25,000 mg/kg body weight. The minimum lethal dose (MLD) in humans has not been established. There is no specific antidote, but gastric lavage is recommended, followed by supportive treatment. Where necessary, this may include intravenous dextrose-saline with potassium, administered with caution.

Store in a cool and dry place, protected from light.

Anticholinergics (antimuscarinics)/ Anti-spasmodics

Propantheline Bromide acts by dual mechanism of action.

• Specific anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites
• Direct effect upon smooth muscle (musculotropic).

This medication is a muscarinic antagonist having antispasmodic properties. It reduces the effect of acetylcholine, a chemical released from nerves that stimulates muscles, by blocking the receptors for acetylcholine on smooth muscle. It also has a direct relaxing effect on smooth muscle. In addition, Propantheline inhibits gastrointestinal motility and decreases gastric acid secretion and controls excessive pharyngeal, tracheal and bronchial secretions. Other secretions like pancreatic juice, sweat and saliva are also reduced.

The usual initial adult dose of Propantheline Bromide is 75 mg daily. One tablet 30 min before each meal (15 mg three times daily). Two tablets at bedtime Dosage adjustment should be made according to the patient's individual response and tolerance. But the maximum daily dosage should not exceed 120 mg.

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

The adverse effects of Propantheline Bromide are usually dose-related and are usually reversible when the therapy is discontinued. Variable degrees of dry mouth, dry skin, mydriasis might be noted. Other reported adverse effects include urinary retention, nausea, vomiting, constipation, headache, nervousness, mental confusion etc.

Propantheline Bromide is contraindicated in patients with-

• Hypersensitivity to Propantheline bromide or other anticholinergic agents;
• Glaucoma;
• Obstructive disease of the gastrointestinal tract (pyloroduodenal stenosis, paralytic ileus etc.);
• Obstructive uropathy (e.g. prostatic hypertrophy) intestinal atony of elderly;
• Myasthenia gravis.

Propantheline Bromide should be used with caution in the elderly and in all patients with autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac tachyarrhythmias, hypertension, since anticholinergics may aggravate this condition.

Antacids or Absorbent Antidiarrhoeals may reduce the absorption of propantheline bromide, therefore resulting in a reduction of its therapeutic effectiveness. Therefore, take two to three hours apart from doses of propantheline bromide. Anticholinergics may delay absorption of other medication given concomitantly. Significant drug interaction also occurs with concomitant use of digoxin, haloperidol, corticosteroides, ketoconazole, levodopa, opioid analgesics, phenothiazines, urinary alkalizers.

Propantheline Bromide is in pregnancy category C. Animal reproduction studies have not been conducted with propantheline bromide. Propantheline bromide should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in milk. Because many drugs are excreted in milk, caution should be exercised when propantheline bromide is administered to a nursing woman. Suppression of lactation may occur with anticholinergic drugs.

The symptoms of overdosage with Propantheline Bromide progress from an intensification of the usual side effects (from nausea and vomiting) to CNS disturbances (from restlessness and excitement to psychotic behaviour), circulatory changes, (flushing, fall in blood pressure, circulatory failure), respiratory failure, paralysis.

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

Theophylline is indicated for the-

• Control of acute asthma.
• Management of chronic asthma (For both Symptomatic and prophylactic treatment).
• For controlling nocturnal asthma and early morning wheezing.
• Management of chronic obstructive lung disease (Chronic bronchitis and emphysema) and acute exacerbation of chronic obstructive lung disease.
• Control of apnea of pre-maturity.

Bronchodilator, Theophylline & related drugs

Theophylline is a bronchodilator, structurally classified as a Methylxanthine. Theophylline has two distinct actions in the airways of patients with reversible obstruction; smooth muscle relaxation and suppression of the response of the airways to stimuli. Theophylline also increases the force of contraction of diaphragmatic muscles. The half-life of Theophylline is influenced by a number of known variables. In adult nonsmokers with uncomplicated asthma the half-life ranges from 3 to 9 hours

The dose of theophylline must be individualized on the basis of peak serum theophylline concentration measurements in order to achieve a dose that will provide maximum potential benefit with minimal risk of adverse effects. Most of the sustained release preparations may be administered every 12 hours in adults while administration every 8 hours may be necessary in some children with markedly rapid hepatic
metabolism of theophylline. The recommended maintenance dose within accepted therapeutic range is as follows :

• 16 years or older: 10 mg/Kg/day (Do not exceed 900 mg/day)
• 12 years-15 years: 13 mg/Kg/day
• 9-11 years: 16 mg/Kg/day
• 1 year-8 years: 24-24 mg/Kg/day
• 6 months-1 year: 12-18 mg/Kg/day
• 1-6 months: 10 mg/Kg/day.

Generally side effects are rare at normal dosage. It may include gastrointestinal discomfort, headache, nausea, insomnia and hypotension. CNS stimulation and diuresis may also occur, especially in children.

Theophylline is contraindicated in patients with hypersensitivity to Theophylline or any other component of the product.

Careful consideration is needed for various interacting drugs and physiologic conditions that can alter Theophylline clearance. Dosage adjustment is required prior to initiation of Theophylline therapy, prior to increases in Theophylline dose, and during follow up. The dose of Theophylline selected for initiation of therapy should be low and, if tolerated, increased slowly over a period of time.

Theophylline should not be used concurrently with other preparations containing xanthine derivatives. The clearance of theophylline is increased by barbiturates, carbamazepine, lithium, phenytoin, rifampicin and sulphinpyrazone and it may therefore be necessary to increase dosage. On the other hand, the clearance of the drug is reduced by allopurinol, cimetidine, ciprofloxacin, corticosteroids, erythromycin, frusemide, isoprenaline, oral contraceptive and thiabendazole and a reduced dosage may therefore be needed to avoid side effects. Theophylline can potentiate hypokalemia resulting from beta-2-agonist therapy, steroids, diuretics and hypoxia, so serum potassium levels should be monitored in such instances.

It is not known whether Theophylline can cause foetal harm when administered to pregnant woman. Xanthines should be given to a pregnant woman only if clearly needed. Theophylline is excreted into breast milk and may cause irritability or other signs of mild toxicity in nursing human infants. Serious adverse effects in the infant are unlikely unless the mother has toxic serum Theophylline concentrations.

Pediatrics use: The clearance of Theophylline is very low in neonates. Careful attention to dosage selection and monitoring of serum Theophylline concentrations are required in pediatric patients.

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

Flupentixol and Melitracen tablet is indicated in-

• Anxiety
• Depression
• Apathy
• Psychogenic depression.
• Depressive neurosses.
• Masked depression.
• Psychosomatic affections accompanied by anxiety and apathy.
• Menopausal depressions.
• Dysphoria and depression in alcoholics and drug addicts.

Combined anxiolytics & anti-depressant drugs

This consists of two well known and well proven compounds: flupentixol-a neuroleptic with anxiolytic and antidepressant properties of its own when given in small doses, and melitracen-a bipolar thymoleptic with activating properties in low doses. In combination the compounds render a preparation with antidepressant, anxiolytic and activating properties. Maximal serum concentration is reached in about 4 hours after oral administration of flupentixol and in about 4 hours after oral administration of melitracen. The biological half-life of flupentixol is about 35 hours and that of melitracen is about 19 hours. The combination of flupentixol and melitracen does not seem to influence the pharmacokinetic properties of the individual compounds.

Adults: Usually 2 tablets orally daily in the morning and noon. In severe cases, the morning dose may be increased to 2 tablets.

Elderly patients: 1 tablet in the morning.

Maintenance dose: Usually 1 tablet orally in the morning. In cases of insomnia or severe restlessness, additional treatment with a sedative in the acute phase is recommended.

In the recommended doses side effects are rare. These could be transient restlessness and insomnia.

If previously the patient has been treated with tranquillizers with sedative effect these should be withdrawn gradually.

This tablet may enhance the response to alcohol, barbiturates and other CNS depressants. Simultaneous administration of MAO-inhibitors may cause hypertensive crises. Neuroleptics and thymoleptics reduce the antihypertensive effect of guanethidine and similar acting compounds and thymoleptics enhance the effects of adrenaline and noradrenaline.

This tablet should preferably not be given during pregnancy and lactation.

In cases of overdosage the symptoms of intoxications by melitracen, especially of anticholinergic nature, dominate. More rarely extrapyramidal symptoms due to flupentixol occur. Symptomatic and Supportive. Gastric lavage should be carried out as soon as possible and activated charcoal may be administered. Measures aimed at supporting the respiratory and cardiovascular systems should be instituted. Epinephrine (adrenaline) must not be used for such patients. Convulsions may be treated with diazepam and extrapyramidal symptoms with biperiden.

Store at a temperature not exceeding 30°C in a dry place. Protect from light. Keep out of reach of children.

Theophylline is indicated for the-

• Control of acute asthma.
• Management of chronic asthma (For both Symptomatic and prophylactic treatment).
• For controlling nocturnal asthma and early morning wheezing.
• Management of chronic obstructive lung disease (Chronic bronchitis and emphysema) and acute exacerbation of chronic obstructive lung disease.
• Control of apnea of pre-maturity.

Bronchodilator, Theophylline & related drugs

Theophylline is a bronchodilator, structurally classified as a Methylxanthine. Theophylline has two distinct actions in the airways of patients with reversible obstruction; smooth muscle relaxation and suppression of the response of the airways to stimuli. Theophylline also increases the force of contraction of diaphragmatic muscles. The half-life of Theophylline is influenced by a number of known variables. In adult nonsmokers with uncomplicated asthma the half-life ranges from 3 to 9 hours

The dose of theophylline must be individualized on the basis of peak serum theophylline concentration measurements in order to achieve a dose that will provide maximum potential benefit with minimal risk of adverse effects. Most of the sustained release preparations may be administered every 12 hours in adults while administration every 8 hours may be necessary in some children with markedly rapid hepatic
metabolism of theophylline. The recommended maintenance dose within accepted therapeutic range is as follows :

• 16 years or older: 10 mg/Kg/day (Do not exceed 900 mg/day)
• 12 years-15 years: 13 mg/Kg/day
• 9-11 years: 16 mg/Kg/day
• 1 year-8 years: 24-24 mg/Kg/day
• 6 months-1 year: 12-18 mg/Kg/day
• 1-6 months: 10 mg/Kg/day.

Generally side effects are rare at normal dosage. It may include gastrointestinal discomfort, headache, nausea, insomnia and hypotension. CNS stimulation and diuresis may also occur, especially in children.

Theophylline is contraindicated in patients with hypersensitivity to Theophylline or any other component of the product.

Careful consideration is needed for various interacting drugs and physiologic conditions that can alter Theophylline clearance. Dosage adjustment is required prior to initiation of Theophylline therapy, prior to increases in Theophylline dose, and during follow up. The dose of Theophylline selected for initiation of therapy should be low and, if tolerated, increased slowly over a period of time.

Theophylline should not be used concurrently with other preparations containing xanthine derivatives. The clearance of theophylline is increased by barbiturates, carbamazepine, lithium, phenytoin, rifampicin and sulphinpyrazone and it may therefore be necessary to increase dosage. On the other hand, the clearance of the drug is reduced by allopurinol, cimetidine, ciprofloxacin, corticosteroids, erythromycin, frusemide, isoprenaline, oral contraceptive and thiabendazole and a reduced dosage may therefore be needed to avoid side effects. Theophylline can potentiate hypokalemia resulting from beta-2-agonist therapy, steroids, diuretics and hypoxia, so serum potassium levels should be monitored in such instances.

It is not known whether Theophylline can cause foetal harm when administered to pregnant woman. Xanthines should be given to a pregnant woman only if clearly needed. Theophylline is excreted into breast milk and may cause irritability or other signs of mild toxicity in nursing human infants. Serious adverse effects in the infant are unlikely unless the mother has toxic serum Theophylline concentrations.

Pediatrics use: The clearance of Theophylline is very low in neonates. Careful attention to dosage selection and monitoring of serum Theophylline concentrations are required in pediatric patients.

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

Theophylline is indicated for the-

• Control of acute asthma.
• Management of chronic asthma (For both Symptomatic and prophylactic treatment).
• For controlling nocturnal asthma and early morning wheezing.
• Management of chronic obstructive lung disease (Chronic bronchitis and emphysema) and acute exacerbation of chronic obstructive lung disease.
• Control of apnea of pre-maturity.

Bronchodilator, Theophylline & related drugs

Theophylline is a bronchodilator, structurally classified as a Methylxanthine. Theophylline has two distinct actions in the airways of patients with reversible obstruction; smooth muscle relaxation and suppression of the response of the airways to stimuli. Theophylline also increases the force of contraction of diaphragmatic muscles. The half-life of Theophylline is influenced by a number of known variables. In adult nonsmokers with uncomplicated asthma the half-life ranges from 3 to 9 hours

The dose of theophylline must be individualized on the basis of peak serum theophylline concentration measurements in order to achieve a dose that will provide maximum potential benefit with minimal risk of adverse effects. Most of the sustained release preparations may be administered every 12 hours in adults while administration every 8 hours may be necessary in some children with markedly rapid hepatic
metabolism of theophylline. The recommended maintenance dose within accepted therapeutic range is as follows :

• 16 years or older: 10 mg/Kg/day (Do not exceed 900 mg/day)
• 12 years-15 years: 13 mg/Kg/day
• 9-11 years: 16 mg/Kg/day
• 1 year-8 years: 24-24 mg/Kg/day
• 6 months-1 year: 12-18 mg/Kg/day
• 1-6 months: 10 mg/Kg/day.

Generally side effects are rare at normal dosage. It may include gastrointestinal discomfort, headache, nausea, insomnia and hypotension. CNS stimulation and diuresis may also occur, especially in children.

Theophylline is contraindicated in patients with hypersensitivity to Theophylline or any other component of the product.

Careful consideration is needed for various interacting drugs and physiologic conditions that can alter Theophylline clearance. Dosage adjustment is required prior to initiation of Theophylline therapy, prior to increases in Theophylline dose, and during follow up. The dose of Theophylline selected for initiation of therapy should be low and, if tolerated, increased slowly over a period of time.

Theophylline should not be used concurrently with other preparations containing xanthine derivatives. The clearance of theophylline is increased by barbiturates, carbamazepine, lithium, phenytoin, rifampicin and sulphinpyrazone and it may therefore be necessary to increase dosage. On the other hand, the clearance of the drug is reduced by allopurinol, cimetidine, ciprofloxacin, corticosteroids, erythromycin, frusemide, isoprenaline, oral contraceptive and thiabendazole and a reduced dosage may therefore be needed to avoid side effects. Theophylline can potentiate hypokalemia resulting from beta-2-agonist therapy, steroids, diuretics and hypoxia, so serum potassium levels should be monitored in such instances.

It is not known whether Theophylline can cause foetal harm when administered to pregnant woman. Xanthines should be given to a pregnant woman only if clearly needed. Theophylline is excreted into breast milk and may cause irritability or other signs of mild toxicity in nursing human infants. Serious adverse effects in the infant are unlikely unless the mother has toxic serum Theophylline concentrations.

Pediatrics use: The clearance of Theophylline is very low in neonates. Careful attention to dosage selection and monitoring of serum Theophylline concentrations are required in pediatric patients.

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