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This is indicated in-

• Hypertension
• Insomnia
• Anxiety
• Tension
• Persistent headache
• Epilepsy
• Hysteria
• Insanity

Herbal and Nutraceuticals

This is an effective medicine to normalize hypertension and anxiety. The main ingredient is Snake root (Rauwolfia serpentina), it acts as an ideal tranquilizer and anti-psychotic. This is very effective in insomnia, hysteria, epilepsy, violent mania, schizophrenia, severe persistent headache, tension and irritated conditions of CNS.

1-2 tablet(s) twice daily or as prescribed by the physician.

No significant side effect has been reported in therapeutic dosage.

There is no known contraindication.

Keep out of reach of the children.

Store at cool and dry place protect from light.

Norethisterone is indicated in:

• Metropathia hemorrhagic (dysfunctional uterine bleeding),
• Premenstrual syndrome,
• Postponement of menstruation,
• Endometriosis &
• Menorrhagia.

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

Norethisterone tablet is a preparation of Norethisterone which has progestational actions similar to those of progesterone, but is a more potent inhibitor of ovulation and has weak estrogenic and androgenic properties. It is used to treat a number of disorders of the menstrual cycle. Norethisterone is absorbed from the gastrointestinal tract and its effects last for at least 24 hours. It is excreted in the urine.

Oral administration. Not intended for use in children.

Metropathia haemorrhagica (dysfunctional uterine bleeding): 1 tablet 3 times daily for 10 days. Bleeding is arrested usually within 1-3 days. A withdrawal bleeding resembling normal menstruation occurs within 2-4 days after discontinuing treatment.

Prophylaxis against recurrence of dysfunctional bleeding: If there are no signs of resumption of normal ovarian function (no rise in the second half of the cycle of the morning temperature, which should be measured daily) recurrence must be anticipated. Cyclical bleeding can be established with 1 tablet twice daily from the 19th to the 26th day of the cycle.

Premenstrual syndrome (including premenstrual mastalgia): Premenstrual symptoms such as headache, migraine, breast discomfort, water retention, tachycardia, and psychological disturbances may be relieved by the administration of 2-3 tablets daily from the 19th to the 26th day of the cycle. Treatment should be repeated for several cycles. When treatment is stopped, the patient may remain symptom-free for a number of months.

Postponement of menstruation: In cases of too frequent menstrual bleeding, and in special circumstances (e.g. operations, travel, sports) the postponement of menstruation is possible. 1 tablet of Norethisterone three times daily, starting 3 days before the expected onset of menstruation. A normal period should occur 2-3 days after the patient has stopped taking tablets.

Endometriosis (pseudo-pregnancy therapy): Long-term treatment is commenced on the 5th day of the cycle with 2 tablets of Norethisterone daily for the first few weeks. In the event of spotting, the dosage is increased to 4, and, if necessary, 5 tablets daily. After bleeding has ceased, the initial dose is usually sufficient. Duration of treatment: 4-6 months continuously, or longer if necessary.

Menorrhagia (hypermenorrhoea): 1 tablet 2-3 times a day from the 19th to the 26th day of the cycle (counting the first day of menstruation as day 1).

Side-effects are more common during the first months after start of intake of Norethisterone, and subside with a duration of treatment. The side-effects are mentioned below:

• Eye disorders- Visual disturbance
• GI disorders- Nausea
• General disorders and administration site- conditions headache, edema
• Nervous system disorders- Migraine, Respiratory, thoracic and mediastinal disorders- Dyspnoea,
• Skin and subcutaneous tissue disorders- Hypersensitivity (eg. Rash, urticaria).

There is a general opinion, based on statistical evidence that users of combined oral contraceptives experience, more often than non-users, venous thromboembolism, arterial thrombosis, including cerebral and myocardial infarction and subarachnoid haemorrhage. Full recovery from such disorders does not always occur, and it should be realized that in a few cases they are fatal. Although Norethisterone does not contain oestrogen, one should keep the possibility of an increased thromboembolic risk in mind, particularly where there is a history of thromboembolic disease or in the presence of severe diabetes with vascular changes or sickle-cell anaemia.

In rare cases benign, and in even rarer cases, malignant liver tumours leading in isolated cases to life-threatening intra-abdominal haemorrhage have been observed after the use of hormonal substances such as the one contained in Norethisterone. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur, a liver tumour should be included in the differential diagnosis and, if necessary, the preparation should be withdrawn.
Norethisterone can influence carbohydrate metabolism. Parameters of carbohydrate metabolism should be examined carefully in all diabetics before and regularly during treatment.

Reasons for stopping Norethisterone immediately-

• Occurrence for the first time of migrainous headaches or more frequent occurrence of unusually severe headaches
• Sudden perceptual disorders (e.g. disturbances of vision or hearing)
• First signs of thrombophlebitis or thromboembolic symptoms, feeling of pain and tightness in the chest
• Pending operations (six weeks beforehand), immobilisation (e.g. after accidents)
• Onset of jaundice, hepatitis, general pruritus
• Significant rise in blood pressure
• Pregnancy.

Not known.

The administration of Norethisterone during pregnancy is contraindicated. Norethisterone should not be used during lactation.

There have been no reports from overdosage and treatment is generally unnecessary. There are no special antidotes and treatment should be symptomatic.

Store below 30°C in a cool & dry place. Keep out of reach of children.

Indicated for the treatment of hyperkalemia. (Hyperkalemia is mainly caused by Acute or Chronic Kidney Disease. Other causes may include Liver failure, Adrenal insufficiency, Use of certain drugs like ARB, ACE inhibitors, Beta blockers or Excessive use of Potassium supplements.)

Calcium Regulator

Sodium Polystyrene Sulfonate is a non-absorbed, cation exchange polymer that contains a sodium counterion. Sodium Polystyrene Sulfonate increases fecal potassium excretion through binding of potassium in the lumen of the gastrointestinal tract. Binding of potassium reduces the concentration of free potassium in the gastrointestinal lumen, resulting in a reduction of serum potassium levels. The practical exchange ratio is 1 mEq K per 1 gram of resin.

As the resin passes along the intestine or is retained in the colon after administration by enema, the sodium ions are partially released and are replaced by potassium ions. This action occurs primarily in the large intestine, which excretes potassium ions to a greater degree than does the small intestine. The efficiency of this process is limited and unpredictably variable.

Adults (including the elderly)-

• Oral Dose: The average daily oral dose for adult is 15 gm to 60 gm (1 Sachet 1-4 times daily).
• Rectal dose: In patients who are unable to intake this medicine orally, rectal administration is possible (as enema). 30 gm to 50 gm of resin is given once or twice daily (at intervals of 6 hours). Each dose is administered as a warm emulsion (at body temperature) in 150 ml to 200 ml of aqueous vehicle (such as plain water, 10% dextrose in water or equal parts of water and 2% Methylcellulose suspension). The emulsion should be agitated gently during administration. The enema should be retained for as long as possible and should be followed by a cleansing enema.

Children-

• Oral dose: In smaller children and infants correspondingly lower doses should be employed. An appropriate initial dose is 1 gm/kg body weight daily in divided doses in acute hyperkalemia. For maintenance therapy, dosage may be reduced to 0.5 gm/kg body weight daily.
• Rectal dose: When refused by mouth, the resin may be given rectally using a dose at least as much as that which would have been given orally. The resin should be suspended in a proportional amount of 10% Dextrose in water. Following retention of the enema, the colon should be irrigated to ensure adequate removal of the resin.

Neonates-

• Rectal dose: Since it is advised that the oral route should not be employed, only rectal administration should be considered. With rectal administration, the minimum effective dosage within the range of 0.5 to 1 gm/kg of resin should be employed. The resultant suspension should be diluted as for adults. Following administration of the resin, the colon should be adequately irrigated to ensure recovery of the resin.

Mixing procedure: Each dose should be given as a suspension in a small quantity of water or, for greater palatability, in sweetened liquid or syrup (but not with orange or other fruit juices which contain potassium). The amount of fluid usually ranges from 20 ml to 100 ml, depending on the dose. It may be simply determined by allowing 3 ml to 4 ml per gram of drug. The prepared suspension should be administered by placing and maintaining the patient in an upright position. The resin may be introduced into the stomach through a plastic tube. If desired, it may be mixed with a diet appropriate for a patient in renal failure.The intensity and duration of therapy depend upon the severity and resistance of hyperkalemia. Sodium Polystyrene Sulfonate should not be heated because it may alter the exchange properties of the resin.

Suspension of this drug should be freshly prepared and not to be stored beyond 24 hours.

The drug may cause some degree of gastric irritation. Anorexia, nausea, vomiting, and constipation may occur especially if high doses are given. Also, hypokalemia, hypocalcemia, and significant sodium retention, and their related clinical manifestations, may occur. Occasionally diarrhea develops. Large doses in elderly individuals may cause fecal impaction. Rare instances of colonic necrosis have been reported. Intestinal obstruction due to concretions of aluminum hydroxide, when used in combination with such resin has been reported.

Sodium Polystyrene Sulfonate is contraindicated in the following conditions: patients with hypokalemia, patients with a history of hypersensitivity to polystyrene sulfonate resins, obstructive bowel disease, neonates with reduced gut motility (postoperatively or drug induced) and oral administration in neonates.

Caution is advised when this product is administered to patients who cannot tolerate even a small increase in sodium loads (i.e., severe congestive heart failure, severe hypertension, or marked edema). In such instances compensatory restriction of sodium intake from other sources may be indicated. In the event of clinically signifcant constipation, treatment with this drug should be discontinued until normal bowel motion is resumed. Magnesium-containing laxatives or sorbitol should not be used.

Sodium Polystyrene Sulfonate may cause drug interactions with Antacids, Non absorbable cation-donating antacids and laxatives, Digitalis, Sorbitol, Lithium, Thyroxine.

Pregnancy Category C. Animal reproduction studies have not been conducted with Sodium Polystyrene Sulfonate. It is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.

Overdosage may result in electrolyte disturbances including hypokalemia, hypocalcemia, and hypomagnesemia. Biochemical disturbances resulting from overdosage may give rise to clinical signs and symptoms of hypokalemia, including: irritability, confusion, delayed thought processes, muscle weakness, hyporeflexia, which may progress to frank paralysis and/or apnea.

Store below 30°C. Keep out of the reach of children. Suspension of this drug should be freshly prepared and not to be stored beyond 24 hours.

Human immunoglobulin-G (IgG) is indicated in:

• Treatment of primary immunodeficiency
• For combined therapy with antibiotics in severe bacterial or viral infections
• A-/Hypogammaglobulinemia
• Idiopathic Thrombocytopenic Purpura
• Guillain-Barre Syndrome
• Kawasaki Syndrome

Vaccines, Anti-sera & Immunoglobulin

Neonates and infants: 5 ml (250 mg)/kg body weight daily on 3 consecutive days. Further infusion may be required depending on the clinical course.

Children and adults:

• For combined therapy with antibiotics in severe bacterial or viral infections and A-/Hypogammaglobulinemia: The usual dosage for adults and children is 2500-5000 mg and 50-150 mg/kg respectively (as a single dose) by intravenous drip infusion or direct intravenous infusion. In case of intravenous injection, it should be injected very slowly.
• For Idiopathic Thrombocytopenic Purpura: The usual dose is 200-400 mg/kg daily given for 5 consecutive days. The additional doses are discontinued if an adequate response does not occur.

For Guillain-Barre Syndrome: The usual dosage is 400 mg/kg daily given for 5 consecutive days.

For Kawasaki Syndrome: The usual dosage is 400 mg/kg daily given for 5 consecutive days (approximately) or 2000 mg daily by intravenous drip infusion. It is recommended that the administration start within 7 days from the onset of Kawasaki Syndrome.

The human normal immunoglobulin is for intravenous use only. For intravenous injection, it should be injected very slowly. The product should be warmed to room or body temperature before use. The human normal immunoglobulin should be infused intravenously at the following rates:

0.01~0.02 ml/kg/min for first 30 minutes and then infusion rate can be gradually increased maximum 0.06 ml/kg/min, if no abnormal sign appears from patients. This infusion can be recalculated by hourly basis; it is 0.6~1.2 ml/kg/hr and 3.6 ml/kg/hr (maximum).

General cautions:

• The human normal immunoglobulin is for intravenous use only.
• When a needle is inserted through the rubber stopper, the needle should be inserted vertically and slowly. If a needle is inserted in a tilted or twisted direction, rubber fragments may be mixed with medicinal product. If there are any rubber fragments, discard the product.
• The vial should be inspected for visible particulate matter and color prior to administration. Do not use the vial if particles are detected. Do not use if turbid.
• Several vials may be pooled into an empty sterile solution container by using aseptic technique, if large doses are to be administered.
• The human normal immunoglobulin cannot be diluted with intravenous fluids. Other medications cannot be injected into the intravenous tubing being used for the human normal immunoglobulin. In case of idiopathic Thrombocytopenic Purpura for children, spontaneous remission should be considered.
• Additional administration to patients with Kawasaki Syndrome should be conducted when the effectiveness of immunoglobulin is insufficient (e.g. symptomatic remission) or additional administration is clearly necessary.(Safety and efficacy for additional administration has not been established)
• Patients should be aware of the risk and discuss with their healthcare professionals and contact them if any signs or symptoms of thrombosis during or after receiving this product develop.
• Healthcare professionals should be aware of the risk for thrombosis with human normal immunoglobulin products and discuss with their patients the risk of thrombosis associated with this product.

There is a possibility that live vaccines (measles, mumps, rubella and varicella vaccine etc.) do not work for the patients who were treated with human normal immunoglobulin. Therefore vaccination should be delayed for 3 months after administration. If human normal immunoglobulin is administered within 14 days after vaccination, re-vaccination should be taken after more than 3 months post administration.

After a large bolus (more than 200 mg/kg) administration for the ITP and Kawasaki disease, use of live vaccines should be delayed more than 6 months. In case of low risk of measles infection, measles vaccination can be delayed more than 11 months.

Contraindicated in patients who have had a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of human normal immunoglobulin.

Human normal immunoglobulin, manufactured from human plasma, has the potential to transmit hepatitis viruses or other viruses. Accordingly, patients with hemophilia or immunodeficiency are recommended to be appropriately vaccinated (Hepatitis A vaccine, etc.), and the attending physician should monitor patients regularly to check any sign of virus infection.

Thrombosis may occur regardless of the route of administration and in the absence of known risk factors (advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity and cardiovascular risk factors). For patients at risk of thrombosis, administer at the minimum concentration possible and at the minimum rate of infusion practicable.

Severe hypersensitivity reactions and anaphylactic reactions with a fall in blood pressure may occur. Patients with antibodies to IgA have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.

Patients with renal disorder (Renal function may deteriorate), Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis and death have been reported in patients receiving IVIG. It should be ensured that patients are not volume-depleted before administration of the IVIG. For patients judged to be at risk for developing renal dysfunction, including patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs, IVIG should be administered at the minimum dose and rate of infusion practicable.

Patients with hemolytic anemia or anemia from blood loss (Human parvovirus B19 infection may occur. In case of infection, continuous anemia may occur.) Patients with cerebrovascular and cardiovascular disorders or case history thereof for example, (Elderly patients with ischemic disease, cardiovascular disorder, cerebrovascular disorders or case of history thereof: a large bolus administration can cause thrombus or embolism such as cerebral infarction, a myocardial infarction, etc, due to blood viscosity increase.)
Patients with high risk of thrombus or embolism (Thrombus or embolism may occur due to an increase of blood viscosity due to large bolus administration.)

Patients with low heart function.

Aseptic Meningitis Syndrome (AMS) has been reported to occur following high dose (e.g. over 1.0 g per kg body weight) of IVIG treatment or rapid infusion of IVIG. The symptoms of AMS usually begin within several hours to 2 days following IVIG treatment. Discontinuation of IVIG treatment has resulted in remission of AMS within several days without sequelae. AMS is characterized by the following signs and symptoms: severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea and vomiting.

Patients should take caution with IgA deficiency. (IVIG may cause anaphylaxis to patients who have anti-IgA)

Human normal immunoglobulin may contain blood group antibodies that may act as hemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin test result and hemolysis. Delayed hemolytic anemia can develop subsequent to IVIG therapy due to enhanced red blood cell sequestration and acute hemolysis, consistent with intravascular hemolysis, has been reported.

Non-cardiogenic pulmonary edema has been reported in patients following IVIG treatment. Transfusion-related acute lung injury is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. Symptoms typically appear within 1 to 6 hours after transfusion.

May interfere with the immune response to live measles vaccine, live mumps vaccine, live rubella vaccine and live varicella vaccine, therefore these vaccines should be given at least 3 wk before or 3 mth after the admin of the immunoglobulins.

Safety for a pregnant woman has not been established. The possibility of parvovirus B-19 infection cannot be excluded from the administration of human normal immunoglobulin. In case of parvovirus B-19 infection, fetal disturbances (Abortion, Hydrops fetalis, fetal death) may occur. Human normal immunoglobulin should be given to a pregnant woman only if the expected benefit justifies the possible risk. Use of this product has not been evaluated in nursing mothers.

Store and transport at 2°C to 8°C. Protect from light. Do not freeze. Keep out of the reach and sight of children

Human immunoglobulin-G (IgG) is indicated in:

• Treatment of primary immunodeficiency
• For combined therapy with antibiotics in severe bacterial or viral infections
• A-/Hypogammaglobulinemia
• Idiopathic Thrombocytopenic Purpura
• Guillain-Barre Syndrome
• Kawasaki Syndrome

Vaccines, Anti-sera & Immunoglobulin

Neonates and infants: 5 ml (250 mg)/kg body weight daily on 3 consecutive days. Further infusion may be required depending on the clinical course.

Children and adults:

• For combined therapy with antibiotics in severe bacterial or viral infections and A-/Hypogammaglobulinemia: The usual dosage for adults and children is 2500-5000 mg and 50-150 mg/kg respectively (as a single dose) by intravenous drip infusion or direct intravenous infusion. In case of intravenous injection, it should be injected very slowly.
• For Idiopathic Thrombocytopenic Purpura: The usual dose is 200-400 mg/kg daily given for 5 consecutive days. The additional doses are discontinued if an adequate response does not occur.

For Guillain-Barre Syndrome: The usual dosage is 400 mg/kg daily given for 5 consecutive days.

For Kawasaki Syndrome: The usual dosage is 400 mg/kg daily given for 5 consecutive days (approximately) or 2000 mg daily by intravenous drip infusion. It is recommended that the administration start within 7 days from the onset of Kawasaki Syndrome.

The human normal immunoglobulin is for intravenous use only. For intravenous injection, it should be injected very slowly. The product should be warmed to room or body temperature before use. The human normal immunoglobulin should be infused intravenously at the following rates:

0.01~0.02 ml/kg/min for first 30 minutes and then infusion rate can be gradually increased maximum 0.06 ml/kg/min, if no abnormal sign appears from patients. This infusion can be recalculated by hourly basis; it is 0.6~1.2 ml/kg/hr and 3.6 ml/kg/hr (maximum).

General cautions:

• The human normal immunoglobulin is for intravenous use only.
• When a needle is inserted through the rubber stopper, the needle should be inserted vertically and slowly. If a needle is inserted in a tilted or twisted direction, rubber fragments may be mixed with medicinal product. If there are any rubber fragments, discard the product.
• The vial should be inspected for visible particulate matter and color prior to administration. Do not use the vial if particles are detected. Do not use if turbid.
• Several vials may be pooled into an empty sterile solution container by using aseptic technique, if large doses are to be administered.
• The human normal immunoglobulin cannot be diluted with intravenous fluids. Other medications cannot be injected into the intravenous tubing being used for the human normal immunoglobulin. In case of idiopathic Thrombocytopenic Purpura for children, spontaneous remission should be considered.
• Additional administration to patients with Kawasaki Syndrome should be conducted when the effectiveness of immunoglobulin is insufficient (e.g. symptomatic remission) or additional administration is clearly necessary.(Safety and efficacy for additional administration has not been established)
• Patients should be aware of the risk and discuss with their healthcare professionals and contact them if any signs or symptoms of thrombosis during or after receiving this product develop.
• Healthcare professionals should be aware of the risk for thrombosis with human normal immunoglobulin products and discuss with their patients the risk of thrombosis associated with this product.

There is a possibility that live vaccines (measles, mumps, rubella and varicella vaccine etc.) do not work for the patients who were treated with human normal immunoglobulin. Therefore vaccination should be delayed for 3 months after administration. If human normal immunoglobulin is administered within 14 days after vaccination, re-vaccination should be taken after more than 3 months post administration.

After a large bolus (more than 200 mg/kg) administration for the ITP and Kawasaki disease, use of live vaccines should be delayed more than 6 months. In case of low risk of measles infection, measles vaccination can be delayed more than 11 months.

Contraindicated in patients who have had a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of human normal immunoglobulin.

Human normal immunoglobulin, manufactured from human plasma, has the potential to transmit hepatitis viruses or other viruses. Accordingly, patients with hemophilia or immunodeficiency are recommended to be appropriately vaccinated (Hepatitis A vaccine, etc.), and the attending physician should monitor patients regularly to check any sign of virus infection.

Thrombosis may occur regardless of the route of administration and in the absence of known risk factors (advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity and cardiovascular risk factors). For patients at risk of thrombosis, administer at the minimum concentration possible and at the minimum rate of infusion practicable.

Severe hypersensitivity reactions and anaphylactic reactions with a fall in blood pressure may occur. Patients with antibodies to IgA have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.

Patients with renal disorder (Renal function may deteriorate), Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis and death have been reported in patients receiving IVIG. It should be ensured that patients are not volume-depleted before administration of the IVIG. For patients judged to be at risk for developing renal dysfunction, including patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs, IVIG should be administered at the minimum dose and rate of infusion practicable.

Patients with hemolytic anemia or anemia from blood loss (Human parvovirus B19 infection may occur. In case of infection, continuous anemia may occur.) Patients with cerebrovascular and cardiovascular disorders or case history thereof for example, (Elderly patients with ischemic disease, cardiovascular disorder, cerebrovascular disorders or case of history thereof: a large bolus administration can cause thrombus or embolism such as cerebral infarction, a myocardial infarction, etc, due to blood viscosity increase.)
Patients with high risk of thrombus or embolism (Thrombus or embolism may occur due to an increase of blood viscosity due to large bolus administration.)

Patients with low heart function.

Aseptic Meningitis Syndrome (AMS) has been reported to occur following high dose (e.g. over 1.0 g per kg body weight) of IVIG treatment or rapid infusion of IVIG. The symptoms of AMS usually begin within several hours to 2 days following IVIG treatment. Discontinuation of IVIG treatment has resulted in remission of AMS within several days without sequelae. AMS is characterized by the following signs and symptoms: severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea and vomiting.

Patients should take caution with IgA deficiency. (IVIG may cause anaphylaxis to patients who have anti-IgA)

Human normal immunoglobulin may contain blood group antibodies that may act as hemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin test result and hemolysis. Delayed hemolytic anemia can develop subsequent to IVIG therapy due to enhanced red blood cell sequestration and acute hemolysis, consistent with intravascular hemolysis, has been reported.

Non-cardiogenic pulmonary edema has been reported in patients following IVIG treatment. Transfusion-related acute lung injury is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. Symptoms typically appear within 1 to 6 hours after transfusion.

May interfere with the immune response to live measles vaccine, live mumps vaccine, live rubella vaccine and live varicella vaccine, therefore these vaccines should be given at least 3 wk before or 3 mth after the admin of the immunoglobulins.

Safety for a pregnant woman has not been established. The possibility of parvovirus B-19 infection cannot be excluded from the administration of human normal immunoglobulin. In case of parvovirus B-19 infection, fetal disturbances (Abortion, Hydrops fetalis, fetal death) may occur. Human normal immunoglobulin should be given to a pregnant woman only if the expected benefit justifies the possible risk. Use of this product has not been evaluated in nursing mothers.

Store and transport at 2°C to 8°C. Protect from light. Do not freeze. Keep out of the reach and sight of children

Motility Stimulants, Motility stimulants/Dopamine antagonist, Prokinetic drugs

Domperidone is a dopamine antagonist that principally blocks the dopamine receptors located in the ChemoreceptorTrigger Zone (CTZ) and stomach. Its gastroprokinetic action is based on its blocking effect of dopamine receptors that have an influence on the motility of the gastrointestinal tract. Due to its weak penetration across the blood-brain barrier, Domperidone has almost no effect on the dopaminergic receptors in the brain, therefore, excluding psychotropic and neurologic side effects. Domperidone restores normal motility and tone of the upper gastrointestinal tract, facilitates gastric emptying, enhances antral and duodenal peristalsis and regulates contraction of the pylorus. Domperidone also increases esophageal peristalsis and lower esophageal sphincter pressure, and thus prevents regurgitation of gastric content.

Domperidone should be taken 15-30 minutes before meals and, if necessary, before retiring.

The usual recommended oral dose of Domperidone is as follows:

• Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily. The maximum dose of Domperidone is 80 mg daily.
• Children: 2-4 ml suspension/10 kg body weight or 0.4-0.8 ml paediatric drops/10 kg body weight, every 6-8 hours daily.

In dyspeptic symptom:

• Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily.
• Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily.

In acute and sub-acute conditions (mainly in acute nausea and vomiting):

• Adults: 20 mg (2 tablets or 20 ml suspension), every 6-8 hours daily
• Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily. (In acute nausea and vomiting maximum period of treatment is 12 weeks).

By rectum in suppositories:

• Adults (including elderly): 30-60 mg every 4-8 hours.
• Children: The maximum daily dose rectally in children's is 30 mg for those weighting 10 to 25 kg. The dose may be divided throughout day if necessary.
• The maximum period of treatment is 12 weeks.

Domperidone may produce hyperprolactinemia (1.3%).This may result in galactorrhea, breast enlargement, and soreness and reduced libido. Dry mouth (1%), thirst, headache (1.2%), nervousness, drowsiness (0.4%), diarrhea (0.2%), skin rash and itching (0.1%) may occur during treatment with domperidone. Extra-pyramidal reactions are seen in 0.05% of patients in clinical studies.

Domperidone is contraindicated to patients having known hypersensitivity to this drug and in the case of neonates. Domperidone should not be used whenever gastrointestinal stimulation might be dangerous i.e., gastrointestinal hemorrhage, mechanical obstruction or perforation. Also contraindicated in patients with prolactin releasing pituitary tumor (prolactinoma).

Domperidone should be used with absolute caution in the case of children because there may be an increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood-brain barrier. Since domperidone is highly metabolized in liver, it should be used with caution in patient with hepatic impairment.

Domperidone may reduce the risk of hypoprolactemic effect of bromocriptine. The action of Domperidone on Gl function may be antagonized by antimuscarinics and opoid analgesics. Care should be exercised when domperidone is administered in combination with MAO (monoamine oxidase) inhibitors.

The safety of domperidone has not been proven and it is therefore not recommended during pregnancy. Animal studies have not demonstrated the teratogenic effect in the fetus. Domperidone may precipitate galactorrhea and improve post-natal lactation. It is secreted in breast milk but in very small quantities insufficient to be considered harmful.

There are no reported cases of overdose.

Store below 30°C, Protected from light & moisture. Keep out of children's reach.

Motility Stimulants, Motility stimulants/Dopamine antagonist, Prokinetic drugs

Domperidone is a dopamine antagonist that principally blocks the dopamine receptors located in the ChemoreceptorTrigger Zone (CTZ) and stomach. Its gastroprokinetic action is based on its blocking effect of dopamine receptors that have an influence on the motility of the gastrointestinal tract. Due to its weak penetration across the blood-brain barrier, Domperidone has almost no effect on the dopaminergic receptors in the brain, therefore, excluding psychotropic and neurologic side effects. Domperidone restores normal motility and tone of the upper gastrointestinal tract, facilitates gastric emptying, enhances antral and duodenal peristalsis and regulates contraction of the pylorus. Domperidone also increases esophageal peristalsis and lower esophageal sphincter pressure, and thus prevents regurgitation of gastric content.

Domperidone should be taken 15-30 minutes before meals and, if necessary, before retiring.

The usual recommended oral dose of Domperidone is as follows:

• Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily. The maximum dose of Domperidone is 80 mg daily.
• Children: 2-4 ml suspension/10 kg body weight or 0.4-0.8 ml paediatric drops/10 kg body weight, every 6-8 hours daily.

In dyspeptic symptom:

• Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily.
• Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily.

In acute and sub-acute conditions (mainly in acute nausea and vomiting):

• Adults: 20 mg (2 tablets or 20 ml suspension), every 6-8 hours daily
• Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily. (In acute nausea and vomiting maximum period of treatment is 12 weeks).

By rectum in suppositories:

• Adults (including elderly): 30-60 mg every 4-8 hours.
• Children: The maximum daily dose rectally in children's is 30 mg for those weighting 10 to 25 kg. The dose may be divided throughout day if necessary.
• The maximum period of treatment is 12 weeks.

Domperidone may produce hyperprolactinemia (1.3%).This may result in galactorrhea, breast enlargement, and soreness and reduced libido. Dry mouth (1%), thirst, headache (1.2%), nervousness, drowsiness (0.4%), diarrhea (0.2%), skin rash and itching (0.1%) may occur during treatment with domperidone. Extra-pyramidal reactions are seen in 0.05% of patients in clinical studies.

Domperidone is contraindicated to patients having known hypersensitivity to this drug and in the case of neonates. Domperidone should not be used whenever gastrointestinal stimulation might be dangerous i.e., gastrointestinal hemorrhage, mechanical obstruction or perforation. Also contraindicated in patients with prolactin releasing pituitary tumor (prolactinoma).

Domperidone should be used with absolute caution in the case of children because there may be an increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood-brain barrier. Since domperidone is highly metabolized in liver, it should be used with caution in patient with hepatic impairment.

Domperidone may reduce the risk of hypoprolactemic effect of bromocriptine. The action of Domperidone on Gl function may be antagonized by antimuscarinics and opoid analgesics. Care should be exercised when domperidone is administered in combination with MAO (monoamine oxidase) inhibitors.

The safety of domperidone has not been proven and it is therefore not recommended during pregnancy. Animal studies have not demonstrated the teratogenic effect in the fetus. Domperidone may precipitate galactorrhea and improve post-natal lactation. It is secreted in breast milk but in very small quantities insufficient to be considered harmful.

There are no reported cases of overdose.

Store below 30°C, Protected from light & moisture. Keep out of children's reach.

Emergency Contraceptive Pill, Oral Contraceptive preparations

Oral contraceptives containing levonorgestrel suppress gonadotropins, inhibiting ovulation. Specifically, levonorgestrel binds to progesterone and androgen receptors and slows the release of gonadotropin-releasing hormone (GnRH) from the hypothalamus. This process results in the suppression of the normal physiological luteinizing hormone (LH) surge that precedes ovulation. It inhibits the rupture of follicles and viable egg release from the ovaries. Levonorgestrel has been proven to be more effective when administered before ovulation.

1.5 mg Tablet: The treatment necessitates the intake of one tablet. The Levonorgestrel tablet must be taken as soon as possible, preferably within 12 hours, after the unprotected intercourse, and no longer than within 72 hours (3 days) after the intercourse. Levonorgestrel can be taken at any moment during the menstrual cycle.

0.75 mg Tablet: The first Levonorgestrel tablet must be taken within 72 hours of the intercourse and the second tablet should be taken after 12 hours of the intake of the first tablet. Levonorgestrel must be taken within 48 hours of unprotected intercourse and in no way after 72 hours because the effectiveness of the medicine starts reducing after 48 hours of intercourse. Levonorgestrel can be taken at any moment during the menstrual cycle.

After using emergency contraception, it is recommended to use a local contraceptive mean (condom, spermicide, and cervical cap) until the next menstrual period resumes. The use of Levonorgestrel does not contraindicate the continuation of regular hormonal contraception. If you have used this medicine while you were using oral contraception (contraceptive pill), you should carry on taking the usual tablets until the end of the treatment. In case no menstrual period occurs in the next pill-free period following the use of Levonorgestrel a pregnancy test should be performed to rule out a pregnancy.

Oral use. The tablet should be taken with a glass of water.

Undesirable effects which have been observed are:

• Nausea and vomiting
• Dizziness, fatigue, headache
• Abdominal pain
• A feeling of breast tenderness
• Bleeding can occur after taking this medicine

Inform the doctor of any unwanted effect which is not mentioned here.

If you have hypersensitivity to levonorgestrel or any of the excipients of Levonorgestrel.

Emergency contraception must be used exceptionally, since:

• It does not allow to prevent a pregnancy in every instance:
• The associated hormonal overdosing is not advisable in the case of regular intake.
• It cannot replace regular contraception.

After taking Levonorgestrel, the menstrual period usually occurs at the expected date nevertheless, it can occur earlier or later by a few days. After taking this medicine, it is therefore mandatory to check the absence of pregnancy by performing a pregnancy test in case of abnormal bleeding at the date of excepted menses or in case of menstrual delay of more than 5 days.

The use of emergency contraception does not replace the necessary precautions against sexually transmitted diseases and the measures to be taken in case of risk of transmission.

Taking this medicine is not recommended if you have had an ectopic pregnancy or if you have had salpingitis or if you have a severe digestive disease that impairs the absorption of medications.

If vomiting would occur within three hours after taking this medicine, it is recommended to take immediately another Levonorgestrel tablet.

Interactions with other medicines and other forms of interaction: Simultaneous administration of certain anticonvulsant agents (phenobarbitone, phenytoin, primidone, carbamazepine), also other medications such as rifampicin, and griseofulvin can reduce or suppress the effectiveness of this emergency contraception.

This medicine is not indicated in case of pre-existing pregnancy and cannot interrupt it. In case of failure of this contraceptive mean persisting pregnancy, epidemiological studies indicate no adverse effects of progestogen on the malformation of a fetus. Lactation is possible. However, since levonorgestrel is secreted into breast milk, it is suggested that you breastfeed immediately before taking each Levonorgestrel tablet and that you skip the nursing following each Levonorgestrel administration.

No acute toxicity has been demonstrated with this medicine in the case of intake of several doses. The efficacy of this medicine is not guaranteed if the dose has been omitted.

Do not exceed the expiry date printed on the outer packaging. Keep the tablet in the outer carton. Keep the medicine away from children. Store in cool dry conditions (below 30° C).

Emergency Contraceptive Pill, Oral Contraceptive preparations

Oral contraceptives containing levonorgestrel suppress gonadotropins, inhibiting ovulation. Specifically, levonorgestrel binds to progesterone and androgen receptors and slows the release of gonadotropin-releasing hormone (GnRH) from the hypothalamus. This process results in the suppression of the normal physiological luteinizing hormone (LH) surge that precedes ovulation. It inhibits the rupture of follicles and viable egg release from the ovaries. Levonorgestrel has been proven to be more effective when administered before ovulation.

1.5 mg Tablet: The treatment necessitates the intake of one tablet. The Levonorgestrel tablet must be taken as soon as possible, preferably within 12 hours, after the unprotected intercourse, and no longer than within 72 hours (3 days) after the intercourse. Levonorgestrel can be taken at any moment during the menstrual cycle.

0.75 mg Tablet: The first Levonorgestrel tablet must be taken within 72 hours of the intercourse and the second tablet should be taken after 12 hours of the intake of the first tablet. Levonorgestrel must be taken within 48 hours of unprotected intercourse and in no way after 72 hours because the effectiveness of the medicine starts reducing after 48 hours of intercourse. Levonorgestrel can be taken at any moment during the menstrual cycle.

After using emergency contraception, it is recommended to use a local contraceptive mean (condom, spermicide, and cervical cap) until the next menstrual period resumes. The use of Levonorgestrel does not contraindicate the continuation of regular hormonal contraception. If you have used this medicine while you were using oral contraception (contraceptive pill), you should carry on taking the usual tablets until the end of the treatment. In case no menstrual period occurs in the next pill-free period following the use of Levonorgestrel a pregnancy test should be performed to rule out a pregnancy.

Oral use. The tablet should be taken with a glass of water.

Undesirable effects which have been observed are:

• Nausea and vomiting
• Dizziness, fatigue, headache
• Abdominal pain
• A feeling of breast tenderness
• Bleeding can occur after taking this medicine

Inform the doctor of any unwanted effect which is not mentioned here.

If you have hypersensitivity to levonorgestrel or any of the excipients of Levonorgestrel.

Emergency contraception must be used exceptionally, since:

• It does not allow to prevent a pregnancy in every instance:
• The associated hormonal overdosing is not advisable in the case of regular intake.
• It cannot replace regular contraception.

After taking Levonorgestrel, the menstrual period usually occurs at the expected date nevertheless, it can occur earlier or later by a few days. After taking this medicine, it is therefore mandatory to check the absence of pregnancy by performing a pregnancy test in case of abnormal bleeding at the date of excepted menses or in case of menstrual delay of more than 5 days.

The use of emergency contraception does not replace the necessary precautions against sexually transmitted diseases and the measures to be taken in case of risk of transmission.

Taking this medicine is not recommended if you have had an ectopic pregnancy or if you have had salpingitis or if you have a severe digestive disease that impairs the absorption of medications.

If vomiting would occur within three hours after taking this medicine, it is recommended to take immediately another Levonorgestrel tablet.

Interactions with other medicines and other forms of interaction: Simultaneous administration of certain anticonvulsant agents (phenobarbitone, phenytoin, primidone, carbamazepine), also other medications such as rifampicin, and griseofulvin can reduce or suppress the effectiveness of this emergency contraception.

This medicine is not indicated in case of pre-existing pregnancy and cannot interrupt it. In case of failure of this contraceptive mean persisting pregnancy, epidemiological studies indicate no adverse effects of progestogen on the malformation of a fetus. Lactation is possible. However, since levonorgestrel is secreted into breast milk, it is suggested that you breastfeed immediately before taking each Levonorgestrel tablet and that you skip the nursing following each Levonorgestrel administration.

No acute toxicity has been demonstrated with this medicine in the case of intake of several doses. The efficacy of this medicine is not guaranteed if the dose has been omitted.

Do not exceed the expiry date printed on the outer packaging. Keep the tablet in the outer carton. Keep the medicine away from children. Store in cool dry conditions (below 30° C).

Atenolol is indicated-

• In the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic.
• For the long-term management of patients with angina pectoris.
• In the management of hemodynamically stable patients with defnite or suspected acute myocardial infarction to reduce cardiovascular mortality.

Beta-adrenoceptor blocking drugs, Beta-blockers

The synthesis of atenolol resulted from attempts to produce a β-adrenoceptor antagonist that would competitively block β1 (cardiac) receptors but have no effect on β2-receptors. It is classified as a β1 selective (cardioselective) β-adrenergic receptor antagonist with no membranestability activity and no partial agonist activity. It is markedly the most hydrophilic of the currently available β- blockers and thus penetrates the lipid of cell membranes poorly

Hypertension: The initial dose of Atenolol is 50 mg given as one tablet a day either alone or added to diuretic therapy. The full effect of this dose will usually be seen within one to two weeks. If an optimal response is not achieved, the dosage should be increased to Atenolol 100 mg given as one tablet a day. Increasing the dosage beyond 100 mg a day is unlikely to produce any further benefit.

Angina Pectoris: The initial dose of Atenolol is 50 mg given as one tablet a day. If an optimal response is not achieved within one week, the dosage should be increased to Atenolol 100 mg given as one tablet a day. Some patients may require a dosage of 200 mg once a day for optimal effect. Twenty-four hour control with once daily dosing is achieved by giving doses larger than necessary to achieve an immediate maximum effect. The maximum early effect on exercise tolerance occurs with doses of 50 to 100 mg, but at these doses the effect at 24 hours is attenuated, averaging about 50% to 75% of that observed with once a day oral doses of 200 mg.

Acute Myocardial Infarction: In patients with definite or suspected acute myocardial infarction, treatment with Atenolol I.V. Injection should be initiated as soon as possible after the patient's arrival in the hospital and after eligibility is established. Treatment should begin with the intravenous administration of 5 mg Atenolol over 5 minutes followed by another 5 mg intravenous injection 10 minutes later. In patients who tolerate the full intravenous dose (10 mg), Atenolol Tablets 50 mg should be initiated 10 minutes after the last intravenous dose followed by another 50 mg oral dose 12 hours later. Thereafter, Atenolol can be given orally either 100 mg once daily or 50 mg twice a day for a further 6-9 days or until discharge from the hospital. If bradycardia or hypotension requiring treatment or any other untoward effects occur, Atenolol should be discontinued.

In a series of investigations in the treatment of acute myocardial infarction, bradycardia and hypotension occurred more commonly, as expected for any beta blocker. In addition, a variety of adverse efects has been reported with other beta-adrenergic blocking agents, and may be considered potential adverse efects of Atenolol.

• Hematologic: Agranulocytosis.
• Allergic: Fever, combined with aching and sore throat, laryngospasm, and respiratory distress.
• Central Nervous System: Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation of time and place; short term memory loss; emotional lability with slightly clouded sensorium; and, decreased performance on neuropsychometrics.
• Gastrointestinal: Mesenteric arterial thrombosis, ischemic colitis.
• Miscellaneous: There have been reports of skin rashes and/or dry eyes associated with the use of beta-adrenergic blocking drugs. Discontinuance of the drug should be considered if any such reaction is not otherwise explicable. Patients should be closely monitored following cessation of therapy.
• Other: Erythematous rash

Atenolol is contraindicated in-

• Sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure.
• Those patients with a history of hypersensitivity to the atenolol or any of the drug product’s components.

General: Patients already on a beta blocker must be evaluated carefully before Atenolol is administered. Initial and subsequent Atenolol dosages can be adjusted downward depending on clinical observations including pulse and blood pressure. Atenolol may aggravate peripheral arterial circulatory disorders.

Impaired Renal Function: The drug should be used with caution in patients with impaired renal function.

Geriatric Use:

• Hypertension and Angina Pectoris: Due to Coronary Atherosclerosis: Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
• Acute Myocardial Infarction: Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Evaluation of patients with hypertension or myocardial infarction should always include assessment of renal function.

Pregnancy Category D. Caution should be exercised when Atenolol is administered to a nursing woman. Clinically significant bradycardia has been reported in breast-fed infants. Premature infants, or infants with impaired renal function, may be more likely to develop adverse effects.

Elderly Patients or Patients with Renal Impairment: Atenolol is excreted by the kidneys; consequently dosage should be adjusted in cases of severe impairment of renal function. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, refecting greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. The following maximum oral dosages are recommended for elderly, renal impaired patients and for patients with renal impairment due to other causes:

• Creatinine clearance 15-35 ml/min/1.73 m²: Maximum dosage 50 mg daily
• Creatinine clearance <15 mL/min/1.73 m²: Maximum dosage 25 mg daily

Some renal impaired or elderly patients being treated for hypertension may require a lower starting dose of Atenolol: 25 mg given as one tablet a day. Patients on hemodialysis should be given 25 mg or 50 mg after each dialysis; this should be done under hospital supervision as marked falls in blood pressure can occur.

Overdosage with Atenolol has been reported with patients surviving acute doses as high as 5 g. One death was reported in a man who may have taken as much as 10 g acutely. The predominant symptoms reported following Atenolol overdose are lethargy, disorder of respiratory drive, wheezing, sinus pause and bradycardia. Additionally, common efects associated with overdosage of any beta-adrenergic blocking agent and which might also be expected in Atenolol overdose are congestive heart failure, hypotension, bronchospasm and/or hypoglycemia. Treatment of overdose should be directed to the removal of any unabsorbed drug by induced emesis, gastric lavage, or administration of activated charcoal. Atenolol can be removed from the general circulation by hemodialysis. Based on the severity of symptoms, management may require intensive support care and facilities for applying cardiac and respiratory support.

Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.

Atenolol is indicated-

• In the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic.
• For the long-term management of patients with angina pectoris.
• In the management of hemodynamically stable patients with defnite or suspected acute myocardial infarction to reduce cardiovascular mortality.

Beta-adrenoceptor blocking drugs, Beta-blockers

The synthesis of atenolol resulted from attempts to produce a β-adrenoceptor antagonist that would competitively block β1 (cardiac) receptors but have no effect on β2-receptors. It is classified as a β1 selective (cardioselective) β-adrenergic receptor antagonist with no membranestability activity and no partial agonist activity. It is markedly the most hydrophilic of the currently available β- blockers and thus penetrates the lipid of cell membranes poorly

Hypertension: The initial dose of Atenolol is 50 mg given as one tablet a day either alone or added to diuretic therapy. The full effect of this dose will usually be seen within one to two weeks. If an optimal response is not achieved, the dosage should be increased to Atenolol 100 mg given as one tablet a day. Increasing the dosage beyond 100 mg a day is unlikely to produce any further benefit.

Angina Pectoris: The initial dose of Atenolol is 50 mg given as one tablet a day. If an optimal response is not achieved within one week, the dosage should be increased to Atenolol 100 mg given as one tablet a day. Some patients may require a dosage of 200 mg once a day for optimal effect. Twenty-four hour control with once daily dosing is achieved by giving doses larger than necessary to achieve an immediate maximum effect. The maximum early effect on exercise tolerance occurs with doses of 50 to 100 mg, but at these doses the effect at 24 hours is attenuated, averaging about 50% to 75% of that observed with once a day oral doses of 200 mg.

Acute Myocardial Infarction: In patients with definite or suspected acute myocardial infarction, treatment with Atenolol I.V. Injection should be initiated as soon as possible after the patient's arrival in the hospital and after eligibility is established. Treatment should begin with the intravenous administration of 5 mg Atenolol over 5 minutes followed by another 5 mg intravenous injection 10 minutes later. In patients who tolerate the full intravenous dose (10 mg), Atenolol Tablets 50 mg should be initiated 10 minutes after the last intravenous dose followed by another 50 mg oral dose 12 hours later. Thereafter, Atenolol can be given orally either 100 mg once daily or 50 mg twice a day for a further 6-9 days or until discharge from the hospital. If bradycardia or hypotension requiring treatment or any other untoward effects occur, Atenolol should be discontinued.

In a series of investigations in the treatment of acute myocardial infarction, bradycardia and hypotension occurred more commonly, as expected for any beta blocker. In addition, a variety of adverse efects has been reported with other beta-adrenergic blocking agents, and may be considered potential adverse efects of Atenolol.

• Hematologic: Agranulocytosis.
• Allergic: Fever, combined with aching and sore throat, laryngospasm, and respiratory distress.
• Central Nervous System: Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation of time and place; short term memory loss; emotional lability with slightly clouded sensorium; and, decreased performance on neuropsychometrics.
• Gastrointestinal: Mesenteric arterial thrombosis, ischemic colitis.
• Miscellaneous: There have been reports of skin rashes and/or dry eyes associated with the use of beta-adrenergic blocking drugs. Discontinuance of the drug should be considered if any such reaction is not otherwise explicable. Patients should be closely monitored following cessation of therapy.
• Other: Erythematous rash

Atenolol is contraindicated in-

• Sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure.
• Those patients with a history of hypersensitivity to the atenolol or any of the drug product’s components.

General: Patients already on a beta blocker must be evaluated carefully before Atenolol is administered. Initial and subsequent Atenolol dosages can be adjusted downward depending on clinical observations including pulse and blood pressure. Atenolol may aggravate peripheral arterial circulatory disorders.

Impaired Renal Function: The drug should be used with caution in patients with impaired renal function.

Geriatric Use:

• Hypertension and Angina Pectoris: Due to Coronary Atherosclerosis: Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
• Acute Myocardial Infarction: Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Evaluation of patients with hypertension or myocardial infarction should always include assessment of renal function.

Pregnancy Category D. Caution should be exercised when Atenolol is administered to a nursing woman. Clinically significant bradycardia has been reported in breast-fed infants. Premature infants, or infants with impaired renal function, may be more likely to develop adverse effects.

Elderly Patients or Patients with Renal Impairment: Atenolol is excreted by the kidneys; consequently dosage should be adjusted in cases of severe impairment of renal function. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, refecting greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. The following maximum oral dosages are recommended for elderly, renal impaired patients and for patients with renal impairment due to other causes:

• Creatinine clearance 15-35 ml/min/1.73 m²: Maximum dosage 50 mg daily
• Creatinine clearance <15 mL/min/1.73 m²: Maximum dosage 25 mg daily

Some renal impaired or elderly patients being treated for hypertension may require a lower starting dose of Atenolol: 25 mg given as one tablet a day. Patients on hemodialysis should be given 25 mg or 50 mg after each dialysis; this should be done under hospital supervision as marked falls in blood pressure can occur.

Overdosage with Atenolol has been reported with patients surviving acute doses as high as 5 g. One death was reported in a man who may have taken as much as 10 g acutely. The predominant symptoms reported following Atenolol overdose are lethargy, disorder of respiratory drive, wheezing, sinus pause and bradycardia. Additionally, common efects associated with overdosage of any beta-adrenergic blocking agent and which might also be expected in Atenolol overdose are congestive heart failure, hypotension, bronchospasm and/or hypoglycemia. Treatment of overdose should be directed to the removal of any unabsorbed drug by induced emesis, gastric lavage, or administration of activated charcoal. Atenolol can be removed from the general circulation by hemodialysis. Based on the severity of symptoms, management may require intensive support care and facilities for applying cardiac and respiratory support.

Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.

Benzodiazepine sedatives

Bromazepam is a powerful psychotropic agent. In lower dosage, it selectively reduces tension and anxiety. In higher dosage, it shows sedative and muscle-relaxant properties. Bromazepam binds to the GABA-A receptor producing a conformational change and potentiating its inhibitory effects. Other neurotransmitters are not influenced.

Standard dosage: Average dosage for outpatient therapy is 1.5-3 mg up to three times daily. Treatment of outpatients should begin with low doses, gradually increasing to the optimum level.

In severe cases, especially in hospital: 6-12 mg 2 or 3 times daily. The overall treatment generally should not be more than 8-12 weeks. In certain cases extension beyond the maximum treatment period may be necessary; if so, it should be taken with re-evaluation of the patient's status with special expertise.

Elderly and debilitated patients: Elderly patients and those with impaired hepatic functions require lower doses.

Children: Bromazepam is usually not indicated in children, but if the physician feels bromazepam treatment is appropriate, then the dose should be adjusted to their low bodyweight (about 0.1-0.3 mg/kg bodyweight)

Bromazepam tablets are for oral administration

Common side-effects include fatigue, drowsiness, muscle weakness, numbed muscle, reduced alertness, confusion, headache, ataxia etc. These phenomena occur predominantly at the start of therapy and usually disappear with prolonged administration. Anterograde amnesia may occur using therapeutic doses.

Bromazepam is contraindicated in patients with known hypersensitivity to bromazepam, severe respiratory insufficiency, severe hepatic insufficiency or sleep apnea syndrome.

The use of benzodiazepines and benzodiazepine like agents may lead to the development of physical and psychological dependence upon these products. This dependence depends on the dose and duration of treatment; it is also greater in predisposed patients with a history of alcohol. Once physical dependence has developed, termination of the treatment will be accompanied by withdrawal symptoms. These may consist of headache, muscle pain, extreme anxiety, tension, confusion and irritability. Since the risk of withdrawal phenomena and rebound phenomena is greater after abrupt discontinuation of the treatment, it is recommended that the dosage be decreased gradually. Bromazepam is not recommended for the primary treatment of sleeplessness caused by psychotic illness. Caution should be exercised while driving cars or using machineries.

If bromazepam is combined with other centrally active drugs, its sedative effects may be enhanced. These drugs are antidepressants, hypnotics, narcotics, antipsychotics, sedatives, antiepileptic drugs, sedative antihistamines and anesthetics. Co-administration of cimetidine may prolong the eliminiation half-life of bromazepam. Concomitant intake of bromazepam with alcohol should be avoided, because the sedative effect of bromazepam may be intensified by alcohol.

The safety of bromazepam during pregnancy has not been established. As bromazepam is excreted in breast milk, use should be avoided during lactation.

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

Nasal Decongestants & Other Nasal Preparations

Sodium Chloride nasal wash is a non-drug, isotonic saline solution that is used to moisturize nasal membranes. This formulation provides comfort for extensive and continuous use.

Sodium Chloride 0.9% nasal wash moistures inside the nose by dissolving and softening thick or crusty mucus thus helps to remove the mucus from the nose and makes breathing easier. Excess sodium is predominantly excreted by the kidneys with small amounts lost in faeces and sweat.

Nasal Congestion: In infants, 1-2 drops of Sodium Chloride nasal wash in each nostril before feeds will help relieve congestion and allow more effective suckling.

Ear Wax Removal: Allow the Sodium Chloride nasal wash to warm to room temperature before use. It is important to put the drops into the ear carefully. Lie down on one side and fill the ear canal with the drops and wait for a few minutes before standing up. Age: from 6 months onwards. Put 3 to 4 drops into the affected ear(s) 3 to 4 times a day for 3 to 5 days.

How to use the Nasal Spray-

• Shake the bottle gently and remove the dust cover.
• Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
• Gently blow the nose to clear the nostrils.
• Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
• Breathe out through your mouth.
• Repeat the above steps in the same/ other nostril for consecutive doses.

Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-

• Remove the dust cover.
• Gently pull off the nasal applicator.
• Wash the applicator and dust cover in warm water.
• Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
• Gently push the applicator back on the top of the bottle and re-fix the dust cover.

No side effects are expected to occur. However stinging, sneezing, increased nasal discharge, or salty taste may occur in some cases.

Do not share this medication with others. Doing so may increase the risk of infection.

Tell your doctor about your medical history, especially of heart problems (e.g., congestive heart failure), lung problems (pulmonary edema), kidney problems, low levels of potassium (hypokalemia), high levels of sodium (hypernatremia), and any allergies.

Tell your doctor if you are pregnant before using this medication. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

There have been no adverse reports of overdose with Sodium Chloride 0.9% nasal wash.

Keep out of the reach of children. Store at room temperature (between 15°C to 30°C), away from light and moisture.

Nortriptyline is indicated for the treatment of depression and nocturnal enuresis.

Tricyclic & related anti-depressant drugs, Tricyclic Anti-depressant

Nortriptyline, a dibenzocycloheptadiene tricyclic antidepressant, is the primary active metabolite of amitriptyline. It increases synaptic concentration of serotonin and/or norepinephrine in the CNS by blocking the neuronal reuptake of norepinephrine and serotonin.

Depression: 

• Adult: Low dose initially increased as necessary to 75-100 mg daily in divided doses or as a single dose (max. 150 mg daily)
• Adolescent & Elderly: 30-50 mg daily in divided doses; Child not recommended for depression

Nocturnal enuresis:

• Child 7 years: 10 mg
• 8-11 years: 10-20 mg
• Over 11 years: 25-35 mg, 30 minutes before bedtime; max period of treatment (including gradual withdrawal) 3 months- full physical examination and ECG before further course.

The most common side effects include dry mouth, sedation, constipation and increased appetite, mild blurred vision, tinnitus, often euphoria and mania. An occasional side effect is a rapid or irregular heartbeat. Alcohol may exacerbate some of its side effects and should be avoided.

Nortriptyline is contraindicated in patients with hypersensitivity to nortriptyline. Concomitant administration with MAOI is contraindicated. Do not use with or within 2 weeks of stopping an MAOI. Nortriptyline is contraindicated during the acute recovery period after myocardial infarction.

Not intended for treatment of bipolar depression. Avoid abrupt withdrawal. Patient at risk of seizures, with DM, narrow angle glaucoma, urinary retention, prostatic hyperplasia, chronic constipation, history of CV disease. Renal and hepatic impairment. Elderly, childn. Pregnancy and lactation.

Nortriptyline should not be given with adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine, phenylpropanolamine, drugs that are metabolized by CYP4502D6, MAOIs, guanethidine, debrisoquine, bethanidine, clonidine and reserpine etc. Barbiturates may increase the rate of metabolism of nortriptyline.

The safety of nortriptyline for use in pregnancy has not been established. Nortriptyline should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

Symptoms: Severe hypotension, cardiac dysrhythmias, shock, CHF, pulmonary oedema, convulsions, and CNS depression, including coma; changes in ECG.

Management: Symptomatic and supportive treatment. Admin IV Na bicarbonate, benzodiazepines. Admin activated charcoal to reduce absorption. Emesis is contraindicated. Initiate cardiac monitoring and observe for signs of CNS or resp depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures.

Store at 15-30° C. Protect from light and moisture.

Nortriptyline is indicated for the treatment of depression and nocturnal enuresis.

Tricyclic & related anti-depressant drugs, Tricyclic Anti-depressant

Nortriptyline, a dibenzocycloheptadiene tricyclic antidepressant, is the primary active metabolite of amitriptyline. It increases synaptic concentration of serotonin and/or norepinephrine in the CNS by blocking the neuronal reuptake of norepinephrine and serotonin.

Depression: 

• Adult: Low dose initially increased as necessary to 75-100 mg daily in divided doses or as a single dose (max. 150 mg daily)
• Adolescent & Elderly: 30-50 mg daily in divided doses; Child not recommended for depression

Nocturnal enuresis:

• Child 7 years: 10 mg
• 8-11 years: 10-20 mg
• Over 11 years: 25-35 mg, 30 minutes before bedtime; max period of treatment (including gradual withdrawal) 3 months- full physical examination and ECG before further course.

The most common side effects include dry mouth, sedation, constipation and increased appetite, mild blurred vision, tinnitus, often euphoria and mania. An occasional side effect is a rapid or irregular heartbeat. Alcohol may exacerbate some of its side effects and should be avoided.

Nortriptyline is contraindicated in patients with hypersensitivity to nortriptyline. Concomitant administration with MAOI is contraindicated. Do not use with or within 2 weeks of stopping an MAOI. Nortriptyline is contraindicated during the acute recovery period after myocardial infarction.

Not intended for treatment of bipolar depression. Avoid abrupt withdrawal. Patient at risk of seizures, with DM, narrow angle glaucoma, urinary retention, prostatic hyperplasia, chronic constipation, history of CV disease. Renal and hepatic impairment. Elderly, childn. Pregnancy and lactation.

Nortriptyline should not be given with adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine, phenylpropanolamine, drugs that are metabolized by CYP4502D6, MAOIs, guanethidine, debrisoquine, bethanidine, clonidine and reserpine etc. Barbiturates may increase the rate of metabolism of nortriptyline.

The safety of nortriptyline for use in pregnancy has not been established. Nortriptyline should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

Symptoms: Severe hypotension, cardiac dysrhythmias, shock, CHF, pulmonary oedema, convulsions, and CNS depression, including coma; changes in ECG.

Management: Symptomatic and supportive treatment. Admin IV Na bicarbonate, benzodiazepines. Admin activated charcoal to reduce absorption. Emesis is contraindicated. Initiate cardiac monitoring and observe for signs of CNS or resp depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures.

Store at 15-30° C. Protect from light and moisture.

Tiemonium Methylsulphate is an antispasmodic drug that reduces muscles spasm of the intestine, biliary system, bladder and uterus. It is used in symptomatic treatment of pain related to functional disorders of the digestive tract and biliary system. It is also indicated for the treatment of spasm and pain in urological and gynaecological diseases.

Anticholinergics

Tiemonium Methylsulphate a competitive antagonist of Acetylcholine, Histamine and strengthens of calcium bond with membrane phospholipids and proteins. Thus inhibits intracellular contractile protein of visceral cell which causes inhibition of visceral spasm and pain.

Tablet/Syrup-

• Adult: usual dose is 2-6 tablets or 3-9 teaspoonfuls syrup daily in divided doses.
• Children: 3 ml/kg or 6 mg/kg body weight daily in divided doses.

Injection: 1 Tiemonium Methylsulphate Injection 3 times daily, through Intravenous route slowly or Intramuscular route.

Suppository: 20 mg Tiemonium Methylsulphate suppository two or three times daily, through rectal route.

Tiemonium Methylsulphate may have the risk of hypotension & tachycardia in certain individuals.

It should not be used in urethroprostatic disorder involving a risk of urine retension. It is contraindicated in patient with having risk of angle closure glaucoma.

Caution should be taken during treatment of patients with disorders of the prostate. Caution should also be taken in case of chronic bronchitis, coronary insufficiency, ambient hyperthermia, renal & hepatic insufficiency. The risks of visual disturbances can make it dangerous to drive or use machines.

Tiemonium methylsulphate tablet should not be used with other drugs without prior consult of a registered physician to avoid possible drug interaction.

The results of animal studies of Tiemonium Methylsulphate did not reveal any teratogenic effects; no deformities have been reported up till now with normal use. In absence of sufficient data, prudence should be the rule for nursing mothers although no problems have been reported with normal use.

Paediatric use: safety and effectiveness of Tiemonium methylsulphate in paediatric patients have not been established.

Geriatric use: Efficacy and safety were maintained with increasing age.

There is not available data regarding the overdose of Tiemonium methylsulphate tablet.

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

Tiemonium Methylsulphate is an antispasmodic drug that reduces muscles spasm of the intestine, biliary system, bladder and uterus. It is used in symptomatic treatment of pain related to functional disorders of the digestive tract and biliary system. It is also indicated for the treatment of spasm and pain in urological and gynaecological diseases.

Anticholinergics

Tiemonium Methylsulphate a competitive antagonist of Acetylcholine, Histamine and strengthens of calcium bond with membrane phospholipids and proteins. Thus inhibits intracellular contractile protein of visceral cell which causes inhibition of visceral spasm and pain.

Tablet/Syrup-

• Adult: usual dose is 2-6 tablets or 3-9 teaspoonfuls syrup daily in divided doses.
• Children: 3 ml/kg or 6 mg/kg body weight daily in divided doses.

Injection: 1 Tiemonium Methylsulphate Injection 3 times daily, through Intravenous route slowly or Intramuscular route.

Suppository: 20 mg Tiemonium Methylsulphate suppository two or three times daily, through rectal route.

Tiemonium Methylsulphate may have the risk of hypotension & tachycardia in certain individuals.

It should not be used in urethroprostatic disorder involving a risk of urine retension. It is contraindicated in patient with having risk of angle closure glaucoma.

Caution should be taken during treatment of patients with disorders of the prostate. Caution should also be taken in case of chronic bronchitis, coronary insufficiency, ambient hyperthermia, renal & hepatic insufficiency. The risks of visual disturbances can make it dangerous to drive or use machines.

Tiemonium methylsulphate tablet should not be used with other drugs without prior consult of a registered physician to avoid possible drug interaction.

The results of animal studies of Tiemonium Methylsulphate did not reveal any teratogenic effects; no deformities have been reported up till now with normal use. In absence of sufficient data, prudence should be the rule for nursing mothers although no problems have been reported with normal use.

Paediatric use: safety and effectiveness of Tiemonium methylsulphate in paediatric patients have not been established.

Geriatric use: Efficacy and safety were maintained with increasing age.

There is not available data regarding the overdose of Tiemonium methylsulphate tablet.

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

Tiemonium Methylsulphate is an antispasmodic drug that reduces muscles spasm of the intestine, biliary system, bladder and uterus. It is used in symptomatic treatment of pain related to functional disorders of the digestive tract and biliary system. It is also indicated for the treatment of spasm and pain in urological and gynaecological diseases.

Anticholinergics

Tiemonium Methylsulphate a competitive antagonist of Acetylcholine, Histamine and strengthens of calcium bond with membrane phospholipids and proteins. Thus inhibits intracellular contractile protein of visceral cell which causes inhibition of visceral spasm and pain.

Tablet/Syrup-

• Adult: usual dose is 2-6 tablets or 3-9 teaspoonfuls syrup daily in divided doses.
• Children: 3 ml/kg or 6 mg/kg body weight daily in divided doses.

Injection: 1 Tiemonium Methylsulphate Injection 3 times daily, through Intravenous route slowly or Intramuscular route.

Suppository: 20 mg Tiemonium Methylsulphate suppository two or three times daily, through rectal route.

Tiemonium Methylsulphate may have the risk of hypotension & tachycardia in certain individuals.

It should not be used in urethroprostatic disorder involving a risk of urine retension. It is contraindicated in patient with having risk of angle closure glaucoma.

Caution should be taken during treatment of patients with disorders of the prostate. Caution should also be taken in case of chronic bronchitis, coronary insufficiency, ambient hyperthermia, renal & hepatic insufficiency. The risks of visual disturbances can make it dangerous to drive or use machines.

Tiemonium methylsulphate tablet should not be used with other drugs without prior consult of a registered physician to avoid possible drug interaction.

The results of animal studies of Tiemonium Methylsulphate did not reveal any teratogenic effects; no deformities have been reported up till now with normal use. In absence of sufficient data, prudence should be the rule for nursing mothers although no problems have been reported with normal use.

Paediatric use: safety and effectiveness of Tiemonium methylsulphate in paediatric patients have not been established.

Geriatric use: Efficacy and safety were maintained with increasing age.

There is not available data regarding the overdose of Tiemonium methylsulphate tablet.

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

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.

This is indicated in

• Mild to moderate mixed anxiety/depression
• Emotional disturbance
• Sleep disorder
• Gastric problems

Combined anxiolytics & anti-depressant drugs

Nortriptyline hydrochloride is a tricyclic antidepressant. Nortriptyline inhibits the uptake of norepinephrine and serotonin at nerve terminals. In contrast to its parent compound amitriptyline which is equally potent in inhibiting the uptake of norepinephrine and serotonin, Nortriptyline has a greater effect on norepinephrine reuptake than on serotonin reuptake.

Fluphenazine is a tranquilizer of the phenothiazine type with piperazine side chain. Fluphenazine primarily acts as a neuroleptic drug whose main therapeutic effect is believed to reside in potent dopamine (specially D2) receptor antagonism.

Adults: One tablet 2 to 3 times daily.

Tardive dyskinesias have been reported in phenothiazine therapy; usually after prolonged courses given at doses adequately to control psychotic illness. Blood dyscrasia, Malignant Neuroleptic syndrome and sudden death have been reported rarely. Agranulocytosis is a rare but potentially fatal adverse effect of Nortriptyline Hydrochloride.

It is contraindicated in :

• History of gradual epilepsy or organic brain damage
• Blood dyscrasia
• Severe cardiac insufficiency
• Renal or liver damage
• Patients taking monoamine oxidase inhibitor (MAOI)
• Younger children
• Hypersensitivity to any component of the preparation

Precautions should be taken in patients with glaucoma, prostate enlargement, cardiac failure and myocardial infarction, and in concurrent administration with CNS depressants. The drug may impair alertness and abilities to drive a car or operate machinery.

Interactions with barbiturates, alcohol, and narcotic drugs may occur, so central depressants should be administered with caution.

The safety in human pregnancy has not been yet established. The use of this drug in lactation is not recommended, as it is excreted in breast milk.

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