Max PLUS-M

Each mL of ampoule of solution for injection contains the following excipients: Polysorbate 20 4 mg, sodium chloride 1.5 mg, sodium ascorbate 10 mg, anhydrous dibasic sodium phosphate 7.6 mg, monobasic sodium phosphate monohydrate 1.8 mg and disodium edetate dihydrate 1.1 mg. It has a pH of 7.2 (6.5-8). Calcitriol (Max PLUS-M) does not contain a preservative.

Calcitriol (Max PLUS-M) is (5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-1α,3β,25-triol. Its molecular formula is C₂₇H₄₄O₃.

The other names frequently used are 1α,25-dihydroxycholecalciferol; 1α,25-dihydroxy-vitamin D3; 1,25-DHCC; 1,25(OH)₂D3; and 1,25-diOHC.

Calcitriol (Max PLUS-M) is a colorless, crystalline compound which occurs naturally in humans. It is soluble in organic solvents but relatively insoluble in water.

Each Calcium carbonate (Max PLUS-M) milk powd contains: Energy Density 1 kCal/mL. Energy Distribution: Protein: Fat: CHO 13:37:50, Protein 32.5 g/L, CHO 125.7 g/L, Fat 42 g/L, Na 500 mg/L, K 1,250 mg/L, Mg 200 mg/L, P 500 mg/L, osmolality 300 mOsmol/kg H₂O.

Each Calcium carbonate (Max PLUS-M) oral liqd (ready-to-drink) contains: Energy Density 1 kCal/mL. Energy Distribution: Protein: Fat: CHO 14:32:54, Protein 35 g/L, CHO 135 g/L, Fat 36 g/L, Na 1,000 mg/L, K 1,200 mg/L, Mg 280 mg/L, P 870 mg/L, osmolality 330 mOsmol/kg H₂O.

Calcium carbonate (Max PLUS-M) is specifically formulated for the dietary management of malnutrition and other medical conditions with increased nutritional needs that cannot be met through diet modification alone.

Special Features: Calcium carbonate (Max PLUS-M) is isotonic (low osmolality); 100% complex carbohydrate; 20% of fat as MCT; lactose-free; unflavoured.

A member of the vitamin B family that stimulates the hematopoietic system. It is present in the liver and kidney and is found in mushrooms, spinach, yeast, green leaves, and grasses (poaceae). Folic acid (Max PLUS-M) is used in the treatment and prevention of folate deficiencies and megaloblastic anemia. [PubChem]

Mecobalamin (Max PLUS-M) also contains the following inactive ingredients: Lactose, maize starch, microcrystalline cellulose, povidone (K-30), purified talc, anhydrous colloidal silica, hypromellose, macrogol, titanium dioxide, isopropyl alcohol, dicholoromethane, red iron oxide and yellow iron oxide.

The 4-methanol form of vitamin B 6 which is converted to pyridoxal phosphate which is a coenzyme for synthesis of amino acids, neurotransmitters (serotonin, norepinephrine), sphingolipids, aminolevulinic acid. Although pyridoxine and Vitamin B 6 are still frequently used as synonyms, especially by medical researchers, this practice is erroneous and sometimes misleading (EE Snell; Ann NY Acad Sci, vol 585 pg 1, 1990).

Predialysis Patients

Calcitriol (Max PLUS-M) (Calcitriol (Max PLUS-M)) is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism.

Dialysis Patients

Calcitriol (Max PLUS-M) (Calcitriol (Max PLUS-M)) is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, Calcitriol (Max PLUS-M) (Calcitriol (Max PLUS-M)) administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization.

Hypoparathyroidism Patients

Calcitriol (Max PLUS-M) (Calcitriol (Max PLUS-M)) is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.

this Calcium carbonate (Max PLUS-M) is useful for the temporary relief of occasional indigestion and heartburn. Frequent, daily or nightly symptoms usually mean a more serious problem. Antacids by themselves do not correct these problems. The medications that are now available to treat acid problems are generally superior to antacids.

The second and more important use of Calcium carbonate (Max PLUS-M) is as a source of calcium, necessary for bones and teeth and to prevent osteoporosis. A quart of milk contains about 1500 mg of calcium which is about what you need. Otherwise this or a similar calcium preparation can be taken.

Folic acid (Max PLUS-M) is used in the treatment and prevention of the folate deficiency state. It does not correct folate deficiency due to dihydrofolate reductase inhibitors. Folic acid (Max PLUS-M) is also used in women of child-bearing potential and pregnant women to protect against neural tube defects in their offspring. It is also used for the treatment of folate-deficient megaloblastic anaemia, chronic haemolytic states such as thalassaemia major or sickle-cell anaemia.

Mecobalamin (Max PLUS-M) (doxacurium chloride) is a long-acting neuromuscular blocking agent, indicated to provide skeletal muscle relaxation as an adjunct to general anesthesia, for endotracheal intubation or to facilitate mechanical ventilation.

* Sideroblastic anaemia

* Treatment and prophylaxis of Vitamin B6 (Max PLUS-M) deficiency states

Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are available in the foods that you eat. Vitamin D is necessary for strong bones and teeth.

Lack of vitamin D may lead to a condition called rickets, especially in children, in which bones and teeth are weak. In adults it may cause a condition called osteomalacia, in which calcium is lost from bones so that they become weak. Your doctor may treat these problems by prescribing vitamin D for you. Vitamin D is also sometimes used to treat other diseases in which calcium is not used properly by the body.

Ergocalciferol is the form of vitamin D used in vitamin supplements.

Some conditions may increase your need for vitamin D. These include:

• Alcoholism
• Intestine diseases
• Kidney disease
• Liver disease
• Overactivity of the parathyroid glands with kidney failure
• Pancreas disease
• Surgical removal of stomach

In addition, individuals and breast-fed infants who lack exposure to sunlight, as well as dark-skinned individuals, may be more likely to have a vitamin D deficiency. Increased need for vitamin D should be determined by your health care professional.

Alfacalcidol, calcifediol, Calcitriol (Max PLUS-M), and dihydrotachysterol are forms of vitamin D used to treat hypocalcemia (not enough calcium in the blood). Alfacalcidol, calcifediol, and Calcitriol (Max PLUS-M) are also used to treat certain types of bone disease that may occur with kidney disease in patients who are undergoing kidney dialysis.

Claims that vitamin D is effective for treatment of arthritis and prevention of nearsightedness or nerve problems have not been proven. Some psoriasis patients may benefit from vitamin D supplements; however, controlled studies have not been performed.

Injectable vitamin D is given by or under the supervision of a health care professional. Some strengths of ergocalciferol and all strengths of alfacalcidol, calcifediol, Calcitriol (Max PLUS-M), and dihydrotachysterol are available only with your doctor's prescription. Other strengths of ergocalciferol are available without a prescription. However, it may be a good idea to check with your health care professional before taking vitamin D on your own. Taking large amounts over long periods may cause serious unwanted effects.

Antacids are taken by mouth to relieve heartburn, sour stomach, or acid indigestion. They work by neutralizing excess stomach acid. Some Calcium carbonate (Max PLUS-M) combinations also contain simethicone, which may relieve the symptoms of excess gas. Antacids alone or in combination with simethicone may also be used to treat the symptoms of stomach or duodenal ulcers.

With larger doses than those used for the Calcium carbonate (Max PLUS-M) effect, magnesium hydroxide (magnesia) and magnesium oxide antacids produce a laxative effect. The information that follows applies only to their use as an Calcium carbonate (Max PLUS-M).

Some antacids, like aluminum carbonate and aluminum hydroxide, may be prescribed with a low-phosphate diet to treat hyperphosphatemia (too much phosphate in the blood). Aluminum carbonate and aluminum hydroxide may also be used with a low-phosphate diet to prevent the formation of some kinds of kidney stones. Aluminum hydroxide may also be used for other conditions as determined by your doctor.

These medicines are available without a prescription. However, your doctor may have special instructions on the proper use and dose of these medicines for your medical problem.

Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are usually available in the foods that you eat. Folic acid (Max PLUS-M) (vitamin B 9) is necessary for strong blood.

Lack of Folic acid (Max PLUS-M) may lead to anemia (weak blood). Your health care professional may treat this by prescribing Folic acid (Max PLUS-M) for you.

Some conditions may increase your need for Folic acid (Max PLUS-M). These include:

• Alcoholism
• Anemia, hemolytic
• Diarrhea (continuing)
• Fever (prolonged)
• Hemodialysis
• Illness (prolonged)
• Intestinal diseases
• Liver disease
• Stress (continuing)
• Surgical removal of stomach

In addition, infants smaller than normal, breast-fed infants, or those receiving unfortified formulas (such as evaporated milk or goat's milk) may need additional Folic acid (Max PLUS-M).

Increased need for Folic acid (Max PLUS-M) should be determined by your health care professional.

Some studies have found that Folic acid (Max PLUS-M) taken by women before they become pregnant and during early pregnancy may reduce the chances of certain birth defects (neural tube defects).

Claims that Folic acid (Max PLUS-M) and other B vitamins are effective for preventing mental problems have not been proven. Many of these treatments involve large and expensive amounts of vitamins.

Injectable Folic acid (Max PLUS-M) is given by or under the direction of your health care professional. Another form of Folic acid (Max PLUS-M) is available without a prescription.

Pyridoxine is Vitamin B6 (Max PLUS-M). Vitamins occur naturally in foods such as meat, poultry, nuts, whole grains, bananas, and avocados. Vitamin B6 (Max PLUS-M) is important for many processes in the body.

Pyridoxine is used to treat or prevent Vitamin B6 (Max PLUS-M) deficiency. It is also used to treat a certain type of anemia (lack of red blood cells). Pyridoxine injection is also used to treat some types of seizure in babies.

Pyridoxine taken by mouth (oral) is available without a prescription. Injectable pyridoxine must be given by a healthcare professional.

Pyridoxine may also be used for purposes not listed in this medication guide.

The optimal daily dose of Calcitriol (Max PLUS-M) (Calcitriol (Max PLUS-M)) must be carefully determined for each patient. Calcitriol (Max PLUS-M) (Calcitriol (Max PLUS-M)) can be administered orally either as a capsule (0.25 mcg or 0.50 mcg) or as an oral solution (1 mcg/mL). Calcitriol (Max PLUS-M) (Calcitriol (Max PLUS-M)) therapy should always be started at the lowest possible dose and should not be increased without careful monitoring of serum calcium.

The effectiveness of Calcitriol (Max PLUS-M) (Calcitriol (Max PLUS-M)) therapy is predicated on the assumption that each patient is receiving an adequate but not excessive daily intake of calcium. Patients are advised to have a dietary intake of calcium at a minimum of 600 mg daily. The U.S. RDA for calcium in adults is 800 mg to 1200 mg. To ensure that each patient receives an adequate daily intake of calcium, the physician should either prescribe a calcium supplement or instruct the patient in proper dietary measures.

Because of improved calcium absorption from the gastrointestinal tract, some patients on Calcitriol (Max PLUS-M) (Calcitriol (Max PLUS-M)) may be maintained on a lower calcium intake. Patients who tend to develop hypercalcemia may require only low doses of calcium or no supplementation at all.

During the titration period of treatment with Calcitriol (Max PLUS-M) (Calcitriol (Max PLUS-M)), serum calcium levels should be checked at least twice weekly. When the optimal dosage of Calcitriol (Max PLUS-M) (Calcitriol (Max PLUS-M)) has been determined, serum calcium levels should be checked every month (or as given below for individual indications). Samples for serum calcium estimation should be taken without a tourniquet.

Dialysis Patients

The recommended initial dose of Calcitriol (Max PLUS-M) (Calcitriol (Max PLUS-M)) is 0.25 mcg/day. If a satisfactory response in the biochemical parameters and clinical manifestations of the disease state is not observed, dosage may be increased by 0.25 mcg/day at 4 to 8 week intervals. During this titration period, serum calcium levels should be obtained at least twice weekly, and if hypercalcemia is noted, the drug should be immediately discontinued until normocalcemia ensues. Phosphorus, magnesium, and alkaline phosphatase should be determined periodically.

Patients with normal or only slightly reduced serum calcium levels may respond to Calcitriol (Max PLUS-M) (Calcitriol (Max PLUS-M)) doses of 0.25 mcg every other day. Most patients undergoing hemodialysis respond to doses between 0.5 and 1 mcg/day.

Oral Calcitriol (Max PLUS-M) (Calcitriol (Max PLUS-M)) may normalize plasma ionized calcium in some uremic patients, yet fail to suppress parathyroid hyperfunction. In these individuals with autonomous parathyroid hyperfunction, oral Calcitriol (Max PLUS-M) (Calcitriol (Max PLUS-M)) may be useful to maintain normocalcemia, but has not been shown to be adequate treatment for hyperparathyroidism.

Hypoparathyroidism

The recommended initial dosage of Calcitriol (Max PLUS-M) (Calcitriol (Max PLUS-M)) is 0.25 mcg/day given in the morning. If a satisfactory response in the biochemical parameters and clinical manifestations of the disease is not observed, the dose may be increased at 2-to 4-week intervals. During the dosage titration period, serum calcium levels should be obtained at least twice weekly and, if hypercalcemia is noted, Calcitriol (Max PLUS-M) (Calcitriol (Max PLUS-M)) should be immediately discontinued until normocalcemia ensues. Careful consideration should also be given to lowering the dietary calcium intake. Serum calcium, phosphorus, and 24-hour urinary calcium should be determined periodically.

Most adult patients and pediatric patients age 6 years and older have responded to dosages in the range of 0.5 mcg to 2 mcg daily. Pediatric patients in the 1 to 5 year age group with hypoparathyroidism have usually been given 0.25 mcg to 0.75 mcg daily. The number of treated patients with pseudohypoparathyroidism less than 6 years of age is too small to make dosage recommendations.

Malabsorption is occasionally noted in patients with hypoparathyroidism; hence, larger doses of Calcitriol (Max PLUS-M) (Calcitriol (Max PLUS-M)) may be needed.

Predialysis Patients

The recommended initial dosage of Calcitriol (Max PLUS-M) (Calcitriol (Max PLUS-M)) is 0.25 mcg/day in adults and pediatric patients 3 years of age and older. This dosage may be increased if necessary to 0.5 mcg/day.

For pediatric patients less than 3 years of age, the recommended initial dosage of Calcitriol (Max PLUS-M) (Calcitriol (Max PLUS-M)) is 10 to 15 ng/kg/day.

How supplied

Capsules: 0.25 mcg Calcitriol (Max PLUS-M) in soft gelatin, light orange, oval capsules, imprinted with Calcitriol (Max PLUS-M) (Calcitriol (Max PLUS-M)) 0.25 ROCHE; bottles of 30 (NDC 0004-0143-23), and bottles of 100 (NDC 0004-0143-01).

Capsules: 0.5 mcg Calcitriol (Max PLUS-M) in soft gelatin, dark orange, oblong capsules, imprinted with Calcitriol (Max PLUS-M) (Calcitriol (Max PLUS-M)) 0.5 ROCHE; bottles of 100 (NDC 0004-0144-01).

Oral Solution

Calcitriol (Max PLUS-M) (Calcitriol (Max PLUS-M)) Capsules and

Oral Solution should be protected from light.

Store at 59° to 86° F (15° to 30° C).

Distributed by: Roche Laboratories Inc., 340 Nutley Street, New Jersey, NJ 07110-1199. Revised: July 2004. FDA Rev date: 7/7/2004

Usual Adult Dose for Osteoporosis:

2500 to 7500 mg/day orally in 2 to 4 divided doses.

Usual Adult Dose for Hypocalcemia:

900 to 2500 mg/day orally in 2 to 4 divided doses. This dose may be adjusted as needed to achieve a normal serum calcium level.

Usual Adult Dose for Dyspepsia:

300 to 8000 mg/day orally in 2 to 4 divided doses. This dose may be increased as needed and tolerated to decrease symptoms of stomach upset.

Maximum Dose: 5,500 to 7980 mg (depending on product used). Not to exceed maximum daily dosage for a period of greater than 2 weeks unless directed by a physician.

Usual Adult Dose for Duodenal Ulcer:

1250 to 3750 mg/day in 2 to 4 divided doses. This dose may be increased as needed and tolerated to decrease the abdominal discomfort. The major limiting factor to the chronic use of Calcium carbonate (Max PLUS-M) is gastric hypersecretion and acid rebound.

Usual Adult Dose for Gastric Ulcer:

1250 to 3750 mg/day in 2 to 4 divided doses. This dose may be increased as needed and tolerated to decrease the abdominal discomfort. The major limiting factor to the chronic use of Calcium carbonate (Max PLUS-M) is gastric hypersecretion and acid rebound.

Usual Adult Dose for Erosive Esophagitis:

1250 to 3750 mg/day orally in 2 to 4 divided doses. The potential for acid rebound could be detrimental. However, antacids have been frequently used in the management of erosive esophagitis and may be beneficial in decreasing the acidity of gastric contents.

Maximum Dose: 5,500 to 7980 mg (depending on product used). Not to exceed maximum daily dosage for a period of greater than 2 weeks unless directed by a physician.

Usual Adult Dose for Gastroesophageal Reflux Disease:

1250 to 3750 mg/day orally in 2 to 4 divided doses. The potential for acid rebound could be detrimental. However, antacids have been frequently used in the management of erosive esophagitis and may be beneficial in decreasing the acidity of gastric contents.

Maximum Dose: 5,500 to 7980 mg (depending on product used). Not to exceed maximum daily dosage for a period of greater than 2 weeks unless directed by a physician.

Usual Pediatric Dose for Hypocalcemia:

Neonatal:

Hypocalcemia (dose depends on clinical condition and serum calcium level): Dose expressed in mg of elemental calcium: 50 to 150 mg/kg/day in 4 to 6 divided doses; not to exceed 1 g/day

Usual

Dosage:

Calcium carbonate (Max PLUS-M):

Children 2 to 5 years: Childrens Pepto, Mylanta (R) Childrens: 1 tablet (400 mg Calcium carbonate (Max PLUS-M)) as symptoms occur; not to exceed 3 tablets/day

Children 6 to 11 years: Childrens Pepto, Mylanta (R) Childrens: 2 tablets (800 mg Calcium carbonate (Max PLUS-M)) as symptoms occur; not to exceed 6 tablets/day

Children 11 years and older:

Tums (R), Tums (R) E-X: 2 to 4 tablets chewed as symptoms occur; not to exceed 15 tablets [Tums (R)] or 10 tablets [Tums (R) E-X] per day

Tums (R) Ultra: 2 to 3 tablets chewed as symptoms occur; not to exceed 7 tablets per day

Hypocalcemia (dose depends on clinical condition and serum calcium level): Dose expressed in mg of elemental calcium:

Children: 45 to 65 mg/kg/day in 4 divided doses

Treatment of hyperphosphatemia in end-stage renal failure: Children and Adults: Dose expressed in mg of Calcium carbonate (Max PLUS-M): 1 g with each meal; increase as needed; range: 4 to 7 g/day

Hydrofluoric acid (HF) burns (HF concentration less than 20%):

Topical: Various topical calcium preparations have been used anecdotally for treatment of dermal exposure to HF solutions; Calcium carbonate (Max PLUS-M) at concentrations ranging from 2.5% to 33% has been used; a topical Calcium carbonate (Max PLUS-M) preparation must be compounded.

Usual Adult Dose for Megaloblastic Anemia

1 mg orally, intramuscularly, subcutaneously or IV once a day. May continue until clinical symptoms of folate deficiency and the hematological profile have normalized.

Usual Adult Dose for Folic acid (Max PLUS-M) Deficiency

400 to 800 mcg orally, intramuscularly, subcutaneously or IV once a day.

Women of childbearing age, pregnant, and lactating women: 800 mcg orally, intramuscularly, subcutaneously or IV once a day.

Usual Pediatric Dose for Folic acid (Max PLUS-M) Deficiency

Infant:

0.1 mg orally, intramuscularly, subcutaneously or IV once a day.

Child:

Less than 4 years: up to 0.3 mg orally, intramuscularly, subcutaneously or IV once a day.

4 years or older: 0.4 mg orally, intramuscularly, subcutaneously or IV once a day.

Usual Pediatric Dose for Vitamin/Mineral Supplementation

Recommended daily allowance (RDA):

Premature neonates: 50 mcg/day (15 mcg/kg/day).

Full-term neonates and infants 1 to 6 months: 25 to 35 mcg/day.

Children:

1 to 3 years: 150 mcg/day.

4 to 8 years: 200 mcg/day.

9 to 13 years: 300 mcg/day.

14 years and older: 400 mcg/day.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Rarely, a dosage of 2 mg/day may be required, particularly in patients with malabsorption, alcoholism, chronic hemolysis, chronic exfoliative skin disease or who are on concomitant anticonvulsant therapy.

Dialysis

Folic acid (Max PLUS-M) is removed by both hemodialysis and peritoneal dialysis. The amount removed varies with type equipment used.

Because folate may accumulate in patients with end-stage renal disease, side effects may be more likely in this patient who is undergoing dialysis. Once this patient's body stores of folate are replete, three times a week dosing may be just as beneficial as once daily dosing but should portend a lower risk of side effects.

Other Comments

The recommended daily allowance of Folic acid (Max PLUS-M) for adult males and females ranges from 150 to 200 and 150 to 180 mcg/day, respectively.

There is a potential danger in administering Folic acid (Max PLUS-M) to patients with undiagnosed anemia, since Folic acid (Max PLUS-M) may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress.

Severe megaloblastic anemia may require therapy for 4 to 5 weeks. Once stabilized, if dietary intake is inadequate, maintenance therapy can be started.

Mecobalamin (Max PLUS-M) SHOULD ONLY BE ADMINISTERED INTRAVENOUSLY.

Mecobalamin (Max PLUS-M), like other long-acting neuromuscular blocking agents, displays variability in the duration of its effect. The potential for a prolonged clinical duration of neuromuscular block must be considered when Mecobalamin (Max PLUS-M) is selected for administration. The dosage information provided below is intended as a guide only. Doses should be individualized. Factors that may warrant dosage adjustment include: advancing age, the presence of kidney or liver disease, or obesity (patients weighing ≥ 30% more than ideal body weight for height). The use of a peripheral nerve stimulator will permit the most advantageous use of Mecobalamin (Max PLUS-M), minimize the possibility of overdosage or underdosage, and assist in the evaluation of recovery.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Adults

Initial Doses

When administered as a component of a thiopental/narcotic induction-intubation paradigm as well as for production of long-duration neuromuscular block during surgery, 0.05 mg/kg (2 × ED95) Mecobalamin (Max PLUS-M) produces good-to-excellent conditions for tracheal intubation in 5 minutes in approximately 90% of patients. Lower doses of Mecobalamin (Max PLUS-M) may result in a longer time for development of satisfactory intubation conditions. Clinically effective neuromuscular block may be expected to last approximately 100 minutes on average (range: 39 to 232) following 0.05 mg/kg Mecobalamin (Max PLUS-M) administered to patients receiving balanced anesthesia.

An initial Mecobalamin (Max PLUS-M) dose of 0.08 mg/kg (3 × ED95) should be reserved for instances in which a need for very prolonged neuromuscular block is anticipated. In approximately 90% of patients, good-to-excellent intubation conditions may be expected in 4 minutes after this dose; however, clinically effective block may be expected to persist for as long as 160 minutes or more (range: 110 to 338).

If Mecobalamin (Max PLUS-M) is administered during steady-state isoflurane, enflurane, or halothane anesthesia, reduction of the dose of Mecobalamin (Max PLUS-M) by one third should be considered.

When succinylcholine is administered to facilitate tracheal intubation in patients receiving balanced anesthesia, an initial dose of 0.025 mg/kg (ED95) Mecobalamin (Max PLUS-M) provides about 60 minutes (range: 9 to 145) of clinically effective neuromuscular block for surgery. For a longer duration of action, a larger initial dose may be administered.

Maintenance Doses

Maintenance dosing will generally be required about 60 minutes after an initial dose of 0.025 mg/kg Mecobalamin (Max PLUS-M) or 100 minutes after an initial dose of 0.05 mg/kg Mecobalamin (Max PLUS-M) during balanced anesthesia. Repeated maintenance doses administered at 25% T1 recovery may be expected to be required at relatively regular intervals in each patient. The interval may vary considerably between patients. Maintenance doses of 0.005 and 0.01 mg/kg Mecobalamin (Max PLUS-M) each provide an average 30 minutes (range: 9 to 57) and 45 minutes (range: 14 to 108), respectively, of additional clinically effective neuromuscular block. For shorter or longer desired durations, smaller or larger maintenance doses may be administered.

Children

When administered during halothane anesthesia, an initial dose of 0.03 mg/kg (ED95) produces maximum neuromuscular block in about 7 minutes (range: 5 to 11) and clinically effective block for an average of 30 minutes (range: 12 to 54). Under halothane anesthesia, 0.05 mg/kg produces maximum block in about 4 minutes (range: 2 to 10) and clinically effective block for 45 minutes (range: 30 to 80). Maintenance doses are generally required more frequently in children than in adults. Because of the potentiating effect of halothane seen in adults, a higher dose of Mecobalamin (Max PLUS-M) may be required in children receiving balanced anesthesia than in children receiving halothane anesthesia to achieve a comparable onset and duration of neuromuscular block. Mecobalamin (Max PLUS-M) has not been studied in pediatric patients below the age of 2 years.

Compatibility

Y-site Administration

Mecobalamin (Max PLUS-M) Injection may not be compatible with alkaline solutions with a pH greater than 8.5 (e.g., barbiturate solutions).

Mecobalamin (Max PLUS-M) is compatible with:

• 5% Dextrose Injection, USP
• 0.9% Sodium Chloride Injection, USP
• 5% Dextrose and 0.9% Sodium Chloride Injection, USP
• Lactated Ringer's Injection, USP
• 5% Dextrose and Lactated Ringer's Injection
• Sufenta® (sufentanil citrate) Injection, diluted as directed
• Alfenta® (alfentanil hydrochloride) Injection, diluted as directed
• Sublimaze® (fentanyl citrate) Injection, diluted as directed

Mecobalamin (Max PLUS-M) diluted up to 1:10 in 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP has been shown to be physically and chemically stable when stored in polypropylene syringes at 5° to 25°C (41° to 77°F), for up to 24 hours. Since dilution diminishes the preservative effectiveness of benzyl alcohol, aseptic techniques should be used to prepare the diluted product. Immediate use of the diluted product is preferred, and any unused portion of diluted Mecobalamin (Max PLUS-M) should be discarded after 8 hours.

See also:
What is the most important information I should know about Calcitriol (Max PLUS-M)?

You should not use this medication if you have a severe form of psoriasis (with pus, skin peeling, severe redness).

Before using Calcitriol (Max PLUS-M) topical, tell your doctor if you have low or high levels of calcium in your blood, a calcium disorder or metabolic imbalance, or if you are receiving UV light treatments (phototherapy) for your psoriasis.

Tell your doctor about all other medicines you are using to treat psoriasis. Also tell your doctor if you are taking a diuretic (water pill) or vitamin or mineral supplements that contain calcium or vitamin D.

Calcitriol (Max PLUS-M) topical is for use only on areas of psoriasis. Avoid getting it on healthy skin areas. Calcitriol (Max PLUS-M) topical should not be applied to the face or the vaginal area.

Stop using this medication and call your doctor if you have a serious side effect such as blistering or severe redness, itching, or other irritation of treated skin.

Using Calcitriol (Max PLUS-M) topical can affect your body's ability to metabolize calcium. This can result in high levels of calcium in your blood (hypercalcemia). Symptoms of this condition include nausea, loss of appetite, constipation, increased thirst and urination, muscle weakness, confusion, and feeling tired or restless. Call your doctor if you have any of these symptoms.

See also:
What is the most important information I should know about Calcium carbonate (Max PLUS-M)?

Known hypersensitivity reaction to any of the ingredients of Calcium carbonate (Max PLUS-M).

See also:
What is the most important information I should know about Folic acid (Max PLUS-M)?

Because it may mask the hematologic abnormalities while neurological damage progresses, Folic acid (Max PLUS-M) should not be used in the therapy of patients with vitamin B12 deficiency of any cause, unless there is associated folate deficiency. The Folic acid (Max PLUS-M) content of one tablet a day however, is unlikely to mask pernicious anemia should this condition be present. Also, pregnancy during pernicious anemia is very rare.

Mecobalamin (Max PLUS-M) (doxacurium chloride) is contraindicated in patients with known hypersensitivity to the product and its components. Mecobalamin (Max PLUS-M) (doxacurium chloride) is contraindicated for use in premature infants because the formulation contains benzyl alcohol.

Contraindications for Vitamin B6 (Max PLUS-M) (Vitamin B6 (Max PLUS-M))

Vitamin B6 (Max PLUS-M) is contraindicated in those hypersensitive to any component of a Vitamin B6 (Max PLUS-M)-containing product.

Use Calcitriol (Max PLUS-M) solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Calcitriol (Max PLUS-M) solution is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Calcitriol (Max PLUS-M) solution at home, a health care provider will teach you how to use it. Be sure you understand how to use Calcitriol (Max PLUS-M) solution. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Calcitriol (Max PLUS-M) solution if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Calcitriol (Max PLUS-M) solution and you are using 1 dose every other day, use the missed dose if you remember the same day. If you do not remember the dose until the next day, use the missed dose, and then skip a day. Return to your every other day schedule.

Ask your health care provider any questions you may have about how to use Calcitriol (Max PLUS-M) solution.

Use Calcium carbonate (Max PLUS-M) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Calcium carbonate (Max PLUS-M) by mouth with or without food.
• Many medicines (eg, used for blood clots, immune system suppression, infection, iron supplementation, low blood platelets, osteoporosis, thyroid problems) should not be taken at the same time as Calcium carbonate (Max PLUS-M); their effectiveness may be decreased. Ask your doctor or pharmacist if your dose of Calcium carbonate (Max PLUS-M) should be separated from your dose of any of your other medicines.
• If you miss a dose of Calcium carbonate (Max PLUS-M), take it as soon as you remember. Continue to take it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use Calcium carbonate (Max PLUS-M).

Use Folic acid (Max PLUS-M) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Folic acid (Max PLUS-M) may be administered as an injection by your health care professional.
• If you are using Folic acid (Max PLUS-M) at home, carefully follow the injection procedures taught to you by your health care provider. If the medicine contains particles, is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when full.
• If you miss a dose of Folic acid (Max PLUS-M), use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Folic acid (Max PLUS-M).

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Pyridoxine tablets are taken by mouth. Injectable pyridoxine is injected into a muscle or into a vein through an IV. You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

The recommended dietary allowance of pyridoxine increases with age. Follow your healthcare provider's instructions. You may also consult the Office of Dietary Supplements of the National Institutes of Health, or the U.S. Department of Agriculture (USDA) Nutrient Database (formerly "Recommended Daily Allowances") listings for more information.

Pyridoxine is only part of a complete program of treatment that may also include a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you should eat or avoid to help control your condition.

Store at room temperature away from moisture and heat.

Calcitriol (Max PLUS-M) is a man-made active form of vitamin D. Most people get enough vitamin D from exposure to the sun and from fortified food products (e.g., dairy products, vitamins). Vitamin D helps control parathyroid hormone and the levels of certain minerals (e.g., calcium, phosphorus) that are needed for building and keeping strong bones.

Before regular vitamin D can be used by the body, it needs to be changed to the active form by the liver and kidneys. Calcitriol (Max PLUS-M) is used in patients with kidney disease who can't make enough of the active form of Vitamin D. This medication is also used to prevent and treat certain types of calcium/phosphorus/parathyroid problems that can happen with long-term kidney dialysis or hypoparathyroidism. Calcitriol (Max PLUS-M) is usually used along with specific diet recommendations and sometimes other medications.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to treat and prevent certain bone diseases (rickets, osteomalacia) when regular vitamin D does not work.

How to use Calcitriol (Max PLUS-M)

Take this medication by mouth with or without food, usually once daily or as directed by your doctor. If you are using the liquid form, measure your dose with a special measuring spoon or device. Do not use a normal household spoon since you may not get the correct dose.

Dosage is based on your medical condition and response to therapy. Your doctor may start you on a low dose and adjust the dose slowly to find the best dose for you. Follow your doctor's directions carefully. Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time each day.

It is very important to follow the diet recommended by your doctor to get the most benefit from this medication and to prevent serious side effects. Do not take other supplements/vitamins (e.g., calcium, vitamin D) unless ordered by your doctor.

Certain medications (bile acid sequestrants such as cholestyramine/colestipol, mineral oil, orlistat) can decrease the absorption of vitamin D. Therefore, separate your doses of these medications as far as possible from your doses of Calcitriol (Max PLUS-M) (at least 2 hours apart, longer if possible). It may be easiest to take Calcitriol (Max PLUS-M) at bedtime if you are also taking these other medications. Ask your doctor or pharmacist about finding a good dosing schedule that will work with all your medications.

This medication is used to prevent or treat low blood calcium levels in people who do not get enough calcium from their diets. It may be used to treat conditions caused by low calcium levels such as bone loss (osteoporosis), weak bones (osteomalacia/rickets), decreased activity of the parathyroid gland (hypoparathyroidism), and a certain muscle disease (latent tetany). It may also be used in certain patients to make sure they are getting enough calcium (e.g., women who are pregnant, nursing, or postmenopausal, people taking certain medications such as phenytoin, phenobarbital, or prednisone).

Calcium plays a very important role in the body. It is necessary for normal functioning of nerves, cells, muscle, and bone. If there is not enough calcium in the blood, then the body will take calcium from bones, thereby weakening bones. Having the right amount of calcium is important for building and keeping strong bones.

How to use Calcium carbonate (Max PLUS-M)

Take this medication by mouth with food. If your product contains calcium citrate, then it may be taken with or without food. Follow all directions on the product package, or take as directed by your doctor. For best absorption, if your daily dose is more than 600 milligrams, then divide your dose and space it throughout the day. If you are uncertain about any of the information, consult your doctor or pharmacist.

If you are using the chewable product, chew it well before swallowing.

If you are using the effervescent tablet, allow the tablet to fully dissolve in a glass of water before drinking it. Do not chew or swallow the tablet whole.

If you are using the liquid product or powder, measure the medication with a dose-measuring spoon or device to make sure you get the correct dose. Do not use a household spoon. If the liquid product is a suspension, shake the bottle well before each dose.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

If your doctor has recommended that you follow a special diet, it is very important to follow the diet to get the most benefit from this medication and to prevent serious side effects. Do not take other supplements/vitamins unless ordered by your doctor.

If you think you may have a serious medical problem, seek immediate medical attention.

Folic acid (Max PLUS-M) is the man-made form of folate. Folate is a B-vitamin naturally found in some foods. It is needed to form healthy cells, especially red blood cells.

Folic acid (Max PLUS-M) supplements may come in different forms (such as L-methylfolate, levomefolate, methyltetrahydrofolate). They are used to treat or prevent low folate levels. Low folate levels can lead to certain types of anemia. Conditions that can cause low folate levels include poor diet, pregnancy, alcoholism, liver disease, certain stomach/intestinal problems, kidney dialysis, among others. Women of childbearing age should receive adequate amounts of Folic acid (Max PLUS-M) either through their diet or supplements to prevent infant spinal cord birth defects.

How to use Folic acid (Max PLUS-M)

Take this product by mouth with or without food as directed by your doctor, usually once daily. If you are taking the over-the-counter product, follow all directions on the product package. If you have any questions, ask your doctor or pharmacist.

Dosage is based on your medical condition and response to treatment. Do not increase your dose or take this product more often than directed.

Take this product regularly to get the most benefit from it. To help you remember, take it at the same time each day. Follow the diet plan recommended by your doctor or dietician. See also Notes section.

If your condition persists or worsens, or if you think you may have a serious medical problem, get medical help right away.

It is used for the treatment and prevention of Vitamin B6 (Max PLUS-M) deficiency. It is important for the breakdown of protein, fats, and carbohydrates from foods.

See also:
What other drugs will affect Calcitriol (Max PLUS-M)?

Cholestyramine:

Cholestyramine has been reported to reduce intestinal absorption of fat-soluble vitamins; as such it may impair intestinal absorption of Calcitriol (Max PLUS-M).

Phenytoin/Phenobarbital:

The coadministration of phenytoin or phenobarbital will not affect plasma concentrations of Calcitriol (Max PLUS-M), but may reduce endogenous plasma levels of 25(OH)D3 by accelerating metabolism. Since blood level of Calcitriol (Max PLUS-M) will be reduced, higher doses of Calcitriol (Max PLUS-M) may be necessary if these drugs are administered simultaneously.

Thiazides:

Thiazides are known to induce hypercalcemia by the reduction of calcium excretion in urine. Some reports have shown that the concomitant administration of thiazides with Calcitriol (Max PLUS-M) causes hypercalcemia. Therefore, precaution should be taken when coadministration is necessary.

Digitalis:

Calcitriol (Max PLUS-M) dosage must be determined with care in patients undergoing treatment with digitalis, as hypercalcemia in such patients may precipitate cardiac arrhythmias.

Ketoconazole:

Ketoconazole may inhibit both synthetic and catabolic enzymes of Calcitriol (Max PLUS-M). Reductions in serum endogenous Calcitriol (Max PLUS-M) concentrations have been observed following the administration of 300 mg/day to 1200 mg/day ketoconazole for a week to healthy men. However, in vivo drug interaction studies of ketoconazole with Calcitriol (Max PLUS-M) have not been investigated.

Corticosteroids:

A relationship of functional antagonism exists between vitamin D analogues, which promote calcium absorption, and corticosteroids, which inhibit calcium absorption.

Phosphate-Binding Agents:

Since Calcitriol (Max PLUS-M) also has an effect on phosphate transport in the intestine, kidneys and bones, the dosage of phosphate-binding agents must be adjusted in accordance with the serum phosphate concentration.

Vitamin D:

Since Calcitriol (Max PLUS-M) is the most potent active metabolite of vitamin D3, pharmacological doses of vitamin D and its derivatives should be withheld during treatment with Calcitriol (Max PLUS-M) to avoid possible additive effects and hypercalcemia.

Calcium Supplements:

Uncontrolled intake of additional calcium-containing preparations should be avoided.

Magnesium:

Magnesium-containing preparations (e.g., antacids) may cause hypermagnesemia and should therefore not be taken during therapy with Calcitriol (Max PLUS-M) by patients on chronic renal dialysis.

See also:
What other drugs will affect Calcium carbonate (Max PLUS-M)?

An interaction generally means that one drug may increase or decrease the effect of another drug. Also, the more medications a person takes, the more likely there will be a drug interaction. Antacids do interact with or prevent the absorption of many medications. As a general rule it is best to separate Calcium carbonate (Max PLUS-M) use and any other medications by at least 1 hour. When antacids are only taken occasionally, this seldom presents a serious problem. Since there are so many good medications to reduce stomach acid, some of them over-the-counter, it is unusual to require frequent Calcium carbonate (Max PLUS-M) use during the day and night.

Interactions with this Calcium carbonate (Max PLUS-M) may occur with the following:

* flecainide (Tambocor)

* phenytoin type drugs (Dilantin, Mesantoin, Peganone, Cerebyx)

* iron (Feosol, ferrous sulfate, Nu-Iron)

* quinidine (Quinidex, Quinaglute)

* aspirin, salicylates

* tetracycline (Sumycin, Tetracyn)

See also:
What other drugs will affect Folic acid (Max PLUS-M)?

Medications that interfere with your bodys ability to use folate may also increase the need for this vitamin. Medications can interfere with folate utilization, including: anticonvulsant medications (such as phenytoin, and primidone) metformin (sometimes prescribed to control blood sugar in type 2 diabetes) sulfasalazine (used to control inflammation associated with Crohns disease and ulcerative colitis) triamterene (a diuretic) Methotrexate There has been concern about the interaction between vitamin B12 and Folic acid (Max PLUS-M). Folic acid (Max PLUS-M) supplements can correct the anemia associated with vitamin B12 deficiency. Unfortunately, Folic acid (Max PLUS-M) will not correct changes in the nervous system that result from vitamin B12 deficiency. Permanent nerve damage could theoretically occur if vitamin B12 deficiency is not treated. Therefore, intake of supplemental Folic acid (Max PLUS-M) should not exceed 1000 micrograms (g, sometimes mcg) per day to prevent Folic acid (Max PLUS-M) from masking symptoms of vitamin B12 deficiency. It is important for older adults to be aware of the relationship between Folic acid (Max PLUS-M) and vitamin B12 because they are at greater risk of having a vitamin B12 deficiency. If you are 50 years of age or older, ask your physician to check your B12 status before you take a supplement that contains Folic acid (Max PLUS-M).

Antibiotics: The use of antibiotics may alter the intestinal microflora and may decrease the possible contribution of Mecobalamin (Max PLUS-M) by certain inhabitants of the microflora (eg, Lactobacillus spp) to the body's requirement for the vitamin. This may particularly be a problem for vegetarians. Garlic, onions, leeks, bananas, asparagus and artichokes, among other vegetables and fruits, contain inulins which promote the growth of certain colonic bacteria including Lactobacillus spp.

Cholestyramine:

Colchicine: Colchicine may cause decreased absorption of Mecobalamin (Max PLUS-M).

Colestipol:

H₂-Blockers (Cimetidine, Famotidine, Nizatidine, Ranitidine): Chronic use of H₂-blockers may result to decreased absorption of Mecobalamin (Max PLUS-M). They are unlikely to affect the absorption of supplemental B₁₂.

Metformin: Metformin may decrease the absorption of Mecobalamin (Max PLUS-M). This possible effect may be reversed with oral calcium supplementation.

Nitrous Oxide: Inhalation of the anesthetic agent nitrous oxide (not to be confused with nitric oxide) can produce a functional deficiency. Nitrous oxide forms a complex with cobalt in Mecobalamin (Max PLUS-M), the cofactor for methionine synthase, resulting in inactivation of the enzyme.

Para-Amino Salicylic Acid: Chronic use of the anti-tuberculosis drug may decrease the absorption of Mecobalamin (Max PLUS-M).

Potassium Chloride: It has been reported that potassium chloride may decrease the absorption of Mecobalamin (Max PLUS-M).

Proton Pump Inhibitors (Lansoprazole, Omeprazole, Pantoprazole, Rabeprazole): Chronic use of proton pump inhibitors may result in decreased absorption, naturally found in food sources.

Interactions for Vitamin B6 (Max PLUS-M) (Vitamin B6 (Max PLUS-M))

Amiodarone: Concomitant use of Vitamin B6 (Max PLUS-M) and amiodarone may enhance amiodarone-induced photosensitivity reactions. Doses of Vitamin B6 (Max PLUS-M) greater than 5-10 milligrams/day should be avoided by those taking amiodarone Carbamazepine: Chronic use of carbamazepine may result in a significant decrease in plasma pyridoxal 5-phosphate levels Cycloserine: Cycloserine may react with pyridoxal 5-phosphate to form a metabolically inactive oxime, which may result in a functional Vitamin B6 (Max PLUS-M) deficiency Ethionamide: The use of ethionamide may increase Vitamin B6 (Max PLUS-M) requirements Fosphenytoin: High doses of Vitamin B6 (Max PLUS-M) may lower plasma levels of phenytoin. Fosphenytoin is a prodrug of phenytoin Hydralazine: The use of hydralazine may increase Vitamin B6 (Max PLUS-M) requirements Isoniazid: (isonicotinic acid, INH). Isoniazid reacts with pyridoxal 5-phosphate to form a metabolically inactive hydrazone, which may result in functional Vitamin B6 (Max PLUS-M) deficiency Levodopa: Concomitant use of levodopa and Vitamin B6 (Max PLUS-M) in doses of 5 milligrams or more daily may reverse the therapeutic effects of levodopa. Vitamin B6 (Max PLUS-M) does not reverse the therapeutic effects of levodopa if levodopa is taken concurrently with the levodopa decarboxylase inhibitor carbidopa. Levodopa is typically administered as a combination product with carbidopa

Oral contraceptives: The use of oral contraceptives may increase Vitamin B6 (Max PLUS-M) requirements. This was more the case with the older oral contraceptive agents with high-dose estrogen/progestin. It appears to be less the case with the newer low-dose estrogen/progestin products Penicillamine: Penicillamine may react with pyridoxal 5-phosphate to form a metabolically inactive thiazolidine, which may result in a functional Vitamin B6 (Max PLUS-M) deficiency Phenelzine: Phenelzine may react with pyridoxal 5-phosphate to yield a metabolically inactive hydrazone compound Phenobarbital: High doses of Vitamin B6 (Max PLUS-M) may lower plasma levels of phenobarbital Phenytoin: High doses of Vitamin B6 (Max PLUS-M) may lower plasma levels of phenytoin Theophylline: Theophylline may react with pyridoxal 5-phosphate leading to low plasma levels of the coenzyme. This may increase the risk of theophylline-induced seizures Valproic acid: Chronic use of valproic acid may result in a significant decrease in plasma pyridoxal 5-phosphate levels.

See also:
What are the possible side effects of Calcitriol (Max PLUS-M)?

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rate observed in practice.

Clinical Studies Experience

Calcitriol (Max PLUS-M) Ointment was studied in two vehicle-controlled studies (419 subjects), and in one open label study (324 subjects). The table below describes exposure to Calcitriol (Max PLUS-M) Ointment in 743 subjects, including 239 exposed for 6 months and 116 exposed for one year.

Four hundred and nineteen subjects were treated with Calcitriol (Max PLUS-M) Ointment twice daily for 8 weeks. The population included subjects ages 13 to 87, males (284) and females (135), Caucasians (372) and non-Caucasians (47); with mild (105) to moderate (313) chronic plaque psoriasis.

Among subjects having laboratory monitoring, hypercalcemia was observed in 24% (18/74) of subjects exposed to active drug and in 16% (13/79) of subjects exposed to vehicle, however the elevation were less than 10% above the upper limit of normal

The open label study enrolled 324 subjects with psoriasis who were then treated for up to 52 weeks. Adverse events reported at a rate of greater than or equal to 3% of subjects treated with Calcitriol (Max PLUS-M) Ointment were lab test abnormality (8%), urine abnormality (4%), psoriasis (4%), hyperciuria (3%), and pruritus (3%). Kidney stones were reported in 3 subjects and confirmed in two.

Postmarketing Experience

The following adverse reactions have been identified during the world-wide post-approval use of Calcitriol (Max PLUS-M) Ointment: acute blistering dermatitis, erythema, pruritus, skin burning sensation, and skin discomfort. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

See also:
What are the possible side effects of Calcium carbonate (Max PLUS-M)?

Applies to Calcium carbonate (Max PLUS-M): tablets

Other dosage forms:

• chewable tablets

Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation.

Seek medical attention right away if any of these SEVERE side effects occur while taking Calcium carbonate (Max PLUS-M) (the active ingredient contained in Calcium carbonate (Max PLUS-M))

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; increased urination; loss of appetite; mental or mood changes; nausea; severe or persistent constipation or stomach pain; weakness; vomiting.

See also:
What are the possible side effects of Folic acid (Max PLUS-M)?

Allergic sensitization has been reported following both oral and parenteral administration of Folic acid (Max PLUS-M).

Folic acid (Max PLUS-M) is relatively nontoxic in man. Rare instances of allergic responses to Folic acid (Max PLUS-M) preparations have been reported and have included erythema, skin rash, itching, general malaise, and respiratory difficulty due to bronchospasm. One patient experienced symptoms suggesting anaphylaxis following injection of the drug. Gastrointestinal side effects, including anorexia, nausea, abdominal distention, flatulence, and a bitter or bad taste, have been reported in patients receiving 15 mg Folic acid (Max PLUS-M) daily for 1 month. Other side effects reported in patients receiving 15 mg daily include altered sleep patterns, difficulty in concentrating, irritability, overactivity, excitement, mental depression, confusion, and impaired judgment. Decreased vitamin B12 serum levels may occur in patients receiving prolonged Folic acid (Max PLUS-M) therapy.

In an uncontrolled study, orally administered Folic acid (Max PLUS-M) was reported to increase the incidence of seizures in some epileptic patients receiving phenobarbital, primidone, or diphenylhydantoin. Another investigator reported decreased diphenylhydantoin serum levels in folate-deficient patients receiving diphenylhydantoin who were treated with 5 mg or 15 mg of Folic acid (Max PLUS-M) daily.

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 844-740-7500.

The most frequent adverse effect of nondepolarizing blocking agents as a class consists of an extension of the pharmacological action beyond the time needed for surgery and anesthesia. This effect may vary from skeletal muscle weakness to profound and prolonged skeletal muscle paralysis resulting in respiratory insufficiency and apnea which require manual or mechanical ventilation until recovery is judged to be clinically adequate. Inadequate reversal of neuromuscular block from Mecobalamin (Max PLUS-M) (doxacurium chloride) is possible, as with all nondepolarizing agents. Prolonged neuromuscular block and inadequate reversal may lead to postoperative complications.

Observed in Clinical Trials

Adverse experiences were uncommon among the 1034 surgical patients and volunteers who received Mecobalamin (Max PLUS-M) (doxacurium chloride) and other drugs in US clinical studies in the course of a wide variety of procedures conducted during balanced or inhalational anesthesia. The following adverse experiences were reported in patients administered Mecobalamin (Max PLUS-M) (doxacurium chloride) (all events judged by investigators during the clinical trials to have a possible causal relationship):

Incidence Greater than 1%

None

Incidence Less than 1%

Observed During Clinical Practice

There have been post-marketing reports of severe allergic reactions (anaphylactic and anaphylactoid reactions) with the use of neuromuscular blocking agents of which Mecobalamin (Max PLUS-M) (doxacurium chloride) is a member. These reactions, in some cases, have been life threatening and fatal. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency.

Applies to pyridoxine: capsule, injectable, solution, tablet, tablet enteric coated, tablet extended release

As well as its needed effects, pyridoxine (the active ingredient contained in Vitamin B6 (Max PLUS-M)) may cause unwanted side effects that require medical attention.

Severity: Moderate

If any of the following side effects occur while taking pyridoxine, check with your doctor or nurse as soon as possible:

With large doses

• Clumsiness
• numbness of hands or feet