^
KIT CONTAINS:
EPINEPHRINE AUTO-INJECT (0.3 mg) – 1 no.EPINEPHRINE AUTO-INJECT (0.15 mg) – 1 no.ALBUTEROL SULFATE HFA INHALER (90 mcg) – 1 no.NITROGLYCERIN SUBLINGUAL TABLETS (0.4 mg) – 1 bottle (25 tablets)DIPHENHYDRAMINE HCl INJECTION SOLUTION (50 mg/mL) – 1 vialASPIRIN TABLETS (325 mg) – 1 Pouch (2 nos).DIPHENHYDRAMINE HCl ORAL SOLUTION (118 mL) – 1 bottleGLUCOSE TABLETS – 1 bottle (10 nos).BD PLASTIPAK 3 mL SYRINGE 25GX1-1/2" – 1 no.
BESTDENTAL.COM
^ Tolerance
Excessive use may lead to the development of tolerance. Only the smallest dose required for effective relief of the acute angina attack should be used. A decrease in therapeutic effect of sublingual nitroglycerin may result from use of long-acting nitrates.
^ Disease Interactions
Some patients may be at greater risk for developing adverse reactions after epinephrine administration. Despite these concerns, it should be recognized that the presence of these conditions is not a contraindication to epinephrine administration in an acute, life-threatening situation. Therefore, patients with these conditions, and/or any other person who might be in a position to administer epinephrine injection to a patient experiencing anaphylaxis should be carefully instructed in regard to the circumstances under which epinephrine should be used.
Patients with Heart Disease
Epinephrine should be administered with caution to patients who have heart disease, including patients with cardiac arrhythmias, coronary artery or organic heart disease, or hypertension. In such patients, or in patients who are on drugs that may sensitize the heart to arrhythmias, epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias [see Drug Interactions (7) and Adverse Reactions (6)].
Other Patients and Diseases
Epinephrine should be administered with caution to patients with hyperthyroidism, diabetes, elderly individuals, and pregnant women. Patients with Parkinson’s disease may notice a temporary worsening of symptoms.
^Pediatrics
The safety and effectiveness of Albuterol Sulfate Inhalation Aerosol in pediatric patients below the age of 4 years have not been established.
^ Circulatory Failure And Shock
Nitroglycerin sublingual tablets are contraindicated in patients with acute circulatory failure or shock.
^ Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Patient Information).
This product's label may have been updated. For full prescribing information, please visit www.glenmarkpharma-us.com.
^Questions?
1-800-331-4536 (Mon-Fri 9AM-5PM EST)
^ Description
Nitroglycerin Sublingual Tablets, USP are stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin; as well as calcium stearate, croscarmellose sodium, silica dimethyl silylate and lactose monohydrate.
Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is:
Molecular weight: 227.09 g/mol
^ Emergency Treatment
Epinephrine injection is intended for immediate administration as emergency supportive therapy and is not intended as a substitute for immediate medical care. In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. More than two sequential doses of epinephrine should only be administered under direct medical supervision [see Indications and Usage (1), Dosage and Administration (2) and Patient Counseling Information (17)].
^Active Ingredient (in Each Tablet)
Aspirin 325 mg (NSAID)1
1nonsteroidal anti-inflammatory drug
^Pediatric Use
Diphenhydramine should not be used in neonates and premature infants (see CONTRAINDICATIONS ).
Diphenhydramine may diminish mental alertness, or in the young pediatric patient, cause excitation. Overdosage may cause hallucinations, convulsions or death (see WARNINGS and OVERDOSAGE ).
See also DOSAGE AND ADMINISTRATION section.
^ Pde-5-inhibitors And Sgc-stimulators
Do not use nitroglycerin sublingual tablets in patients who are taking PDE-5 Inhibitors, such as avanafil, sildenafil, tadalafil, vardenafil hydrochloride. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia [see Drug Interactions (7.1)].
Do not use nitroglycerin sublingual tablets in patients who are taking the soluble guanylate cyclase stimulators, such as riociguat. Concomitant use can cause hypotension.
^Antiparkinsonism
For use in parkinsonism, when oral therapy is impossible or contraindicated, as follows: parkinsonism in the elderly who are unable to tolerate more potent agents, mild cases of parkinsonism in other age groups and in other cases of parkinsonism in combination with centrally acting anticholinergic agents.
^Active Ingredient (in Each 5 Ml)
Diphenhydramine HCl 12.5 mg
^Drug Interactions
Diphenhydramine hydrochloride has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.)
MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.
^ Serious Infections At The Injection Site
Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following epinephrine injection for anaphylaxis. Clostridium spores can be present on the skin and introduced into the deep tissue with subcutaneous or intramuscular injection. While cleansing with alcohol may reduce presence of bacteria on the skin, alcohol cleansing does not kill Clostridium spores. To decrease the risk of Clostridium infection, do not inject epinephrine injection into the buttock [see Warnings and Precautions (5.2)]. Advise patients to seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site.
^4 Contraindications
None.
^Teratogenic Effects—pregnancy Category B
Reproduction studies have been performed in rats and rabbits at doses up to 5 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to diphenhydramine hydrochloride. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
^Inactive Ingredients
anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution
^ Recommended Dosage According To Patient Body Weight
^Motion Sickness
For active treatment of motion sickness.
^Overdosage
Antihistamine overdosage reactions may vary from central nervous system depression to stimulation. Stimulation is particularly likely in pediatric patients. Atropine-like signs and symptoms, dry mouth; fixed, dilated pupils; flushing, and gastrointestinal symptoms may also occur.
Stimulants should not be used.
Vasopressors may be used to treat hypotension.
^ Carcinogenesis, Mutagenesis, Impairment Of Fertility
Animal carcinogenesis studies with sublingually administered nitroglycerin have not been performed.
Carcinogenicity potential of nitroglycerin was evaluated in rats receiving up to 434 mg/kg/day of dietary nitroglycerin for 2 years. Rats developed dose-related fibrotic and neoplastic changes in liver, including carcinomas, and interstitial cell tumors in testes. At high dose, the incidences of hepatocellular carcinomas in males was 48% and in females was 33%, compared to 0% in untreated controls. Incidences of testicular tumors were 52% vs. 8% in controls. Lifetime dietary administration of up to 1058 mg/kg/day of nitroglycerin was not tumorigenic in mice.
Nitroglycerin was mutagenic in Ames tests performed in 2 different laboratories. Nevertheless, there was no evidence of mutagenicity in an in vivo dominant lethal assay with male rats treated with doses up to about 363 mg/kg/day, PO, or in ex vivo cytogenetic tests in rat and dog cells.
In a 3-generation reproduction study, rats received dietary nitroglycerin at doses up to about 434 mg/kg/day for 6 months prior to mating of the F0 generation, with treatment continuing through successive F1 and F2 generations. The high dose was associated with decreased feed intake and body weight gain in both sexes at all matings. No specific effect on the fertility of the F0 generation was seen. Infertility noted in subsequent generations, however, was attributed to increased interstitial cell tissue and aspermatogenesis in the high-dose males. In this 3-generation study, there was no clear evidence of teratogenicity.
^Other Information
^Adverse Reactions
The most frequent adverse reactions are italicized.
^Carcinogenesis, Mutagenesis, And Impairment Of Fertility
In a 2-year study in SPRAGUE-DAWLEY ® rats, albuterol sulfate caused a dose-related increase in the incidence of benign leiomyomas of the mesovarium at the above dietary doses of 2 mg/kg (approximately 15 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis and approximately 6 times the maximum recommended daily inhalation dose for children on a mg/m 2 basis). In another study this effect was blocked by the coadministration of propranolol, a nonselective beta-adrenergic antagonist. In an 18-month study in CD-1 mice, albuterol sulfate showed no evidence of tumorigenicity at dietary doses of up to 500 mg/kg (approximately 1700 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis and approximately 800 times the maximum recommended daily inhalation dose for children on a mg/m 2 basis). In a 22-month study in Golden Hamsters, albuterol sulfate showed no evidence of tumorigenicity at dietary doses of up to 50 mg/kg (approximately 225 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis and approximately 110 times the maximum recommended daily inhalation dose for children on a mg/m 2 basis).
Albuterol sulfate was not mutagenic in the Ames test or a mutation test in yeast. Albuterol sulfate was not clastogenic in a human peripheral lymphocyte assay or in an AH1 strain mouse micronucleus assay.
Reproduction studies in rats demonstrated no evidence of impaired fertility at oral doses up to 50 mg/kg (approximately 340 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis).
^ Pregnancy
^Use As A Local Anesthetic
Because of the risk of local necrosis, this drug should not be used as a local anesthetic.
^ Hypertrophic Obstructive Cardiomyopathy
Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.
^ Administration Instructions
^Storage
Protect from light. Keep covered in carton until time of use. Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.For Product Inquiry call 1-877-845-0689.
Manufactured by: Hikma Pharmaceuticals USA Inc.Berkeley Heights, NJ 07922
Revised December 2019
^2 Dosage And Administration
Administer one tablet under the tongue or in the buccal pouch at the first sign of an acute anginal attack. Allow tablet to dissolve without swallowing. One additional tablet may be administered every 5 minutes until relief is obtained. No more than three tablets are recommended within a 15-minute period. If the pain persists after a total of 3 tablets in a 15-minute period, or if the pain is different than is typically experienced, seek prompt medical attention.
Nitroglycerin sublingual tablets may be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack.
For patients with xerostomia, a small sip of water prior to placing the tablet under the tongue may help maintain mucosal hydration and aid dissolution of the tablet.
Administer nitroglycerin sublingual tablets at rest, preferably in the sitting position.
^ Hypersensitivity
Nitroglycerin sublingual tablets are contraindicated in patients who are allergic to nitroglycerin, other nitrates or nitrites or any excipient.
^ Pde-5-inhibitors And Sgc-stimulators
Nitroglycerin sublingual tablets are contraindicated in patients who are using a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE-5). PDE-5-Inhibitors such as avanafil, sildenafil, vardenafil, and tadalafil have been shown to potentiate the hypotensive effects of organic nitrates.
Nitroglycerin sublingual tablets are contraindicated in patients who are taking soluble guanylate cyclase (sGC) stimulators. Concomitant use can cause hypotension.
The time course and dose dependence of these interactions have not been studied, and use within a few days of one another is not recommended. Appropriate supportive care for the severe hypotension has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion.
^Packaging
^General
Urticaria; drug rash; anaphylactic shock; photosensitivity; excessive perspiration; chills; dryness of mouth, nose and throat.
^Information For Patients
Patients taking diphenhydramine hydrochloride should be advised that this drug may cause drowsiness and has an additive effect with alcohol.
Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating appliances, machinery, etc.
^Adults
10 to 50 mg intravenously at a rate generally not exceeding 25 mg/min, or deep intramuscularly; 100 mg if required; maximum daily dosage is 400 mg.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
^Gastrointestinal System
Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation.
^Geriatrics
Albuterol Sulfate Inhalation Aerosol has not been studied in a geriatric population. As with other beta 2-agonists, special caution should be observed when using Albuterol Sulfate Inhalation Aerosol in elderly patients who have concomitant cardiovascular disease that could be adversely affected by this class of drug.
^ Pharmacodynamics
The principal pharmacological action of nitroglycerin is relaxation of vascular smooth muscle. Although venous effects predominate, nitroglycerin produces, in a dose-related manner, dilation of both arterial and venous beds. Dilation of postcapillary vessels, including large veins, promotes peripheral pooling of blood, decreases venous return to the heart, and reduces left ventricular end-diastolic pressure (preload).
Nitroglycerin also produces arteriolar relaxation, thereby reducing peripheral vascular resistance and arterial pressure (afterload), and dilates large epicardial coronary arteries; however, the extent to which this latter effect contributes to the relief of exertional angina is unclear.
Therapeutic doses of nitroglycerin may reduce systolic, diastolic, and mean arterial blood pressure. Effective coronary perfusion pressure is usually maintained, but can be compromised if blood pressure falls excessively, or increased heart rate decreases diastolic filling time.
Elevated central venous and pulmonary capillary wedge pressures, and pulmonary and systemic vascular resistance are also reduced by nitroglycerin therapy. Heart rate is usually slightly increased, presumably due to a compensatory response to the fall in blood pressure. Cardiac index may be increased, decreased, or unchanged. Myocardial oxygen consumption or demand (as measured by the pressure-rate product, tension-time index, and stroke-work index) is decreased and a more favorable supply-demand ratio can be achieved. Patients with elevated left ventricular filling pressures and increased systemic vascular resistance in association with a depressed cardiac index are likely to experience an improvement in cardiac index. In contrast, when filling pressures and cardiac index are normal, cardiac index may be slightly reduced following nitroglycerin administration.
Consistent with the symptomatic relief of angina, digital plethysmography indicates that onset of the vasodilatory effect occurs approximately 1 to 3 minutes after sublingual nitroglycerin administration and reaches a maximum by 5 minutes postdose. Effects persist for at least 25 minutes following nitroglycerin administration.
^Description
Diphenhydramine Hydrochloride Injection is a sterile, nonpyrogenic solution for intravenous or deep intramuscular use as an antihistaminic agent. Each mL contains diphenhydramine hydrochloride 50 mg and benzethonium chloride 100 mcg in Water for Injection. pH 4.0-6.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment.
The chemical name of diphenhydramine hydrochloride is 2-(Diphenylmethoxy)-N,N-dimethylethylamine hydrochloride. The structural formula is as follows:
C17H21NO • HCl MW 291.82
Diphenhydramine hydrochloride occurs as a white crystalline powder and is freely soluble in water and alcohol.
^Dosage And Administration
THIS PRODUCT IS FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION ONLY.
Diphenhydramine Hydrochloride Injection is indicated when the oral form is impractical.
DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.
^ Increased Intracranial Pressure
Nitroglycerin sublingual tablets may precipitate or aggravate increased intracranial pressure and thus should not be used in patients with possible increased intracranial pressure (e.g., cerebral hemorrhage or traumatic brain injury).
^Nervous System
Sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, neuritis, convulsions.
^Uses
^ Allergic Reactions Associated With Sulfite
The presence of a sulfite in this product should not deter administration of the drug for treatment of serious allergic or other emergency situations even if the patient is sulfite-sensitive.
Epinephrine is the preferred treatment for serious allergic reactions or other emergency situations even though this product contains sodium bisulfite, a sulfite that may, in other products, cause allergic-type reactions including anaphylactic symptoms or life-threatening or less severe asthmatic episodes in certain susceptible persons.
The alternatives to using epinephrine in a life-threatening situation may not be satisfactory.
^Directions
Chew desired amount of glucose.
Store at room temperature. Do not refrigerate or freeze. Do not expose to excessive heat or moisture.
^Respiratory System
Thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness.
^Pediatric Patients, Other Than Premature Infants And Neonates
5 mg/kg/24 hours or 150 mg/m2/24 hours. Maximum daily dosage is 300 mg. Divide into four doses, administered intravenously at a rate generally not exceeding 25 mg/min, or deep intramuscularly.
^Pregnancy Teratogenic Effects Pregnancy
Albuterol sulfate has been shown to be teratogenic in mice. A study in CD-1 mice given albuterol sulfate subcutaneously showed cleft palate formation in 5 of 111 (4.5%) fetuses at 0.25 mg/kg (less than the maximum recommended daily inhalation dose for adults on a mg/m 2 basis) and in 10 of 108 (9.3%) fetuses at 2.5 mg/kg (approximately 8 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis). The drug did not induce cleft palate formation at a dose of 0.025 mg/kg (less than the maximum recommended daily inhalation dose for adults on a mg/m 2 basis). Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with 2.5 mg/kg of isoproterenol (positive control).
A reproduction study in Stride Dutch rabbits revealed cranioschisis in 7 of 19 (37%) fetuses when albuterol sulfate was administered orally at 50 mg/kg dose (approximately 680 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis).
In an inhalation reproduction study in SPRAGUE-DAWLEY rats, the albuterol sulfate/HFA-134a formulation did not exhibit any teratogenic effects at 10.5 mg/kg (approximately 70 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis).
A study in which pregnant rats were dosed with radiolabeled albuterol sulfate demonstrated that drug-related material is transferred from the maternal circulation to the fetus.
There are no adequate and well-controlled studies of Albuterol Sulfate Inhalation Aerosol or albuterol sulfate in pregnant women. Albuterol Sulfate Inhalation Aerosol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in the offspring of patients being treated with albuterol. Some of the mothers were taking multiple medications during their pregnancies. Because no consistent pattern of defects can be discerned, a relationship between albuterol use and congenital anomalies has not been established.
^How Supplied
Diphenhydramine Hydrochloride Injection, USP 50 mg/mL
^Use In Pediatric Patients
In pediatric patients, especially, antihistamines in overdosage may cause hallucinations, convulsions or death.
As in adults, antihistamines may diminish mental alertness in pediatric patients. In the young pediatric patient, particularly, they may produce excitation.
^Purposes
Pain reliever/fever reducer
^ Signs And Symptoms, Methemoglobinemia
Nitrate overdosage may result in: severe hypotension, persistent throbbing headache, vertigo, palpitation, visual disturbance, flushing and perspiring skin (later becoming cold and cyanotic), nausea and vomiting (possibly with colic and even bloody diarrhea), syncope (especially in the upright posture), methemoglobinemia with cyanosis and anorexia, initial hyperpnea, dyspnea and slow breathing, slow pulse (dicrotic and intermittent), heart block, increased intracranial pressure with cerebral symptoms of confusion and moderate fever, paralysis and coma followed by clonic convulsions, and possibly death due to circulatory collapse.
Case reports of clinically significant methemoglobinemia are rare at conventional doses of organic nitrates. The formation of methemoglobin is dose-related and in the case of genetic abnormalities of hemoglobin that favor methemoglobin formation, even conventional doses of organic nitrates could produce harmful concentrations of methemoglobin.
^Antihistaminic
For amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.
^Hematologic System
Hemolytic anemia, thrombocytopenia, agranulocytosis.
^ Overdosage
Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema because of peripheral vascular constriction together with cardiac stimulation. Treatment consists of a rapidly acting vasodilators or alpha-adrenergic blocking drugs and/or respiratory support.
Epinephrine overdosage can also cause transient bradycardia followed by tachycardia, and these may be accompanied by potentially fatal cardiac arrhythmias. Premature ventricular contractions may appear within one minute after injection and may be followed by multifocal ventricular tachycardia (prefibrillation rhythm). Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block. Treatment of arrhythmias consists of administration of a beta-adrenergic blocking drug such as propranolol.
Overdosage sometimes results in extreme pallor and coldness of the skin, metabolic acidosis, and kidney failure. Suitable corrective measures must be taken in such situations.
^Contraindications
Albuterol Sulfate Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to albuterol or any other Albuterol Sulfate Inhalation Aerosol components.
^ Treatment Of Overdosage
As hypotension associated with nitroglycerin overdose is the result of venodilatation and arterial hypovolemia, prudent therapy in this situation should be directed toward increase in central fluid volume. No specific antagonist to the vasodilator effects of nitroglycerin is known. Keep the patient recumbent in a shock position and comfortably warm. Passive movement of the extremities may aid venous return. Intravenous infusion of normal saline or similar fluid may also be necessary. Administer oxygen and artificial ventilation, if necessary. If methemoglobinemia is present, administration of methylene blue (1% solution), 1 to 2 mg per kilogram of body weight intravenously, may be required unless the patient is known to have G-6-PD deficiency. If an excessive quantity of nitroglycerin has been recently swallowed gastric lavage may be of use.
As epinephrine is ineffective in reversing the severe hypotensive events associated with overdosage, it is not recommended for resuscitation.
^ Lactation
Risk Summary
There are no data on the presence of epinephrine in human milk, or the effects of epinephrine on the breastfed infant or on milk production. Epinephrine is the first line-medication of choice for treatment of anaphylaxis; it should be used in the same manner in breastfeeding and no-breastfeeding patients.
^Patient Information
Nitroglycerin (nahy-truh-glis-er-in) Sublingual Tablets, USP
Read this information carefully before you start nitroglycerin sublingual tablets and each time you refill your prescription. There may be new information. This information does not replace talking with your doctor. If you have any questions about nitroglycerin sublingual tablets, ask your doctor. Your doctor will know if nitroglycerin sublingual tablets are right for you.
What are Nitroglycerin Sublingual Tablets?
Nitroglycerin sublingual tablets are type of medicine known as an organic nitrate and is a vasodilating agent. It is used to treat a type of chest pain called angina.
What is Angina?
Angina is a pain or discomfort that keeps coming back when part of your heart does not get enough blood. Angina feels like a pressing or squeezing pain, usually in your chest under the breastbone. Sometimes you can feel it in your shoulders, arms, neck, jaws, or back. Nitroglycerin sublingual tablets can relieve this pain.
Who should not use Nitroglycerin Sublingual Tablets?
Do not use nitroglycerin sublingual tablets if you are allergic to organic nitrates (like the active ingredient in nitroglycerin).
You should not take nitroglycerin sublingual tablets if you have the following conditions:
Do not take nitroglycerin sublingual tablets with drugs for erectile dysfunction, like VIAGRA® (sildenafil citrate), CIALIS® (tadalafil), or LEVITRA® (vardenafil hydrochloride), as this may lead to extreme lowering of your blood pressure.
Do not take nitroglycerin sublingual tablets if you take medicines called guanylate cyclase stimulators which include riociguat, a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension.
What should I tell my doctor before taking Nitroglycerin Sublingual Tablets?
Before using nitroglycerin sublingual tablets, tell your doctor if:
How should I take Nitroglycerin Sublingual Tablets?
What should I avoid while taking Nitroglycerin Sublingual Tablets?
What are the possible side effects of Nitroglycerin Sublingual Tablets?
Nitroglycerin sublingual tablets may cause the following side effects:
Tell your doctor if you are concerned about any side effects you experience. These are not all the possible side effects of nitroglycerin sublingual tablets. For a complete list, ask your doctor or pharmacist.
How do I store Nitroglycerin Sublingual Tablets?
Nitroglycerin sublingual tablets should be kept in the original glass container and tightly capped after each use to prevent loss of tablet potency.
Store nitroglycerin sublingual tablets at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
General advice about Nitroglycerin Sublingual Tablets
Sometimes doctors will prescribe a medicine for a condition that is not included in the patient information leaflets. Only use nitroglycerin sublingual tablets the way your doctor told you to. Do not give nitroglycerin sublingual tablets to other people, even if they have the same symptoms you have. They may harm them.
You can ask your pharmacist or doctor for information about nitroglycerin sublingual tablets, or you can call Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115.
Trademarks are the property of their respective owners.
Manufactured by:
Glenmark Pharmaceuticals Limited
India
Manufactured for:
Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430
Questions? 1 (888) 721-7115
www.glenmarkpharma-us.com
October 2021
^ Headache
Nitroglycerin produces dose-related headaches, especially at the start of nitroglycerin therapy, which may be severe and persist but usually subside with continued use.
^3 Dosage Forms And Strengths
Nitroglycerin Sublingual Tablets, USP are supplied as white to off-white, round, flat-faced tablets in three strengths:
0.3 mg (Debossed with “1” on one side and “C” on the other)0.4 mg (Debossed with “2” on one side and “C” on the other)0.6 mg (Debossed with “3” on one side and “C” on the other)
^Clinical Pharmacology
Diphenhydramine hydrochloride is an antihistamine with anticholinergic (drying) and sedative side effects. Antihistamines appear to compete with histamine for cell receptor sites on effector cells.
Diphenhydramine hydrochloride in the injectable form has a rapid onset of action. Diphenhydramine is widely distributed throughout the body, including the CNS. A portion of the drug is excreted unchanged in the urine, while the rest is metabolized via the liver. Detailed information on the pharmacokinetics of Diphenhydramine Hydrochloride Injection is not available.
^Antihistamines Are Also Contraindicated In The Following Conditions
Hypersensitivity to diphenhydramine hydrochloride and other antihistamines of similar chemical structure.
^ Pediatric Use
The safety and effectiveness of nitroglycerin in pediatric patients have not been established.
^Use In The Elderly (approximately Years Or Older)
Antihistamines are more likely to cause dizziness, sedation and hypotension in elderly patients.
^ How Supplied/storage And Handling
Nitroglycerin Sublingual Tablets, USP are supplied as white to off white, round, flat-faced tablets in 3 strengths (0.3 mg, 0.4 mg, and 0.6 mg) in bottles.
Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Nitroglycerin should be kept in the original glass container and must be tightly capped after each use to prevent loss of tablet potency.
^ Ergotamine
Oral administration of nitroglycerin markedly decreases the first-pass metabolism of dihydroergotamine and subsequently increases its oral bioavailability. Ergotamine is known to precipitate angina pectoris. Therefore, patients receiving sublingual nitroglycerin should avoid ergotamine and related drugs or be monitored for symptoms of ergotism if this is not possible.
^ Geriatric Use
Clinical studies of nitroglycerin sublingual tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, 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.
^ Injection-related Complications
Epinephrine injection should only be injected into the anterolateral aspect of the thigh [see Dosage and Administration (2) and Patient Counseling Information (17)].
Do not inject intravenously
Large doses or accidental intravenous injection of epinephrine may result in cerebral hemorrhage due to a sharp rise in blood pressure. Rapidly acting vasodilators can counteract the marked pressor effects of epinephrine if there is such inadvertent administration.
Do not inject into buttock
Injection into the buttock may not provide effective treatment of anaphylaxis. Advise the patient to go immediately to the nearest emergency room for further treatment of anaphylaxis. Additionally, injection into the buttock has been associated with the development of Clostridial infections (gas gangrene). Cleansing with alcohol does not kill bacterial spores, and therefore, does not lower the risk.
Do not inject into digits, hands or feet
Since epinephrine is a strong vasoconstrictor, accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area. Advise the patient to go immediately to the nearest emergency room and to inform the healthcare provider in the emergency room of the location of the accidental injection. Treatment of such inadvertent administration should consist of vasodilation, in addition to further appropriate treatment of anaphylaxis [see Adverse Reactions (6)].
Hold leg firmly during injection
Lacerations, bent needles, and embedded needles have been reported when epinephrine has been injected into the thigh of young children who are uncooperative and kick or move during an injection. To minimize the risk of injection related injury when administering, hold the child’s leg firmly in place and limit movement prior to and during injection.
^ Hypotension
Severe hypotension, particularly with upright posture, may occur with small doses of nitroglycerin particularly in patients with constrictive pericarditis, aortic or mitral stenosis, patients who may be volume-depleted, or are already hypotensive. Hypotension induced by nitroglycerin may be accompanied by paradoxical bradycardia and increased angina pectoris. Symptoms of severe hypotension (nausea, vomiting, weakness, pallor, perspiration and collapse/syncope) may occur even with therapeutic doses.
^Carcinogenesis, Mutagenesis, Impairment Of Fertility
Long-term studies in animals to determine mutagenic and carcinogenic potential have not been performed.
^Purpose
Antihistamine
^Indications And Usage
Diphenhydramine Hydrochloride Injection is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when the oral form is impractical:
^8 Use In Specific Populations
^Cardiovascular System
Hypotension, headache, palpitations, tachycardia, extrasystoles.
^6 Adverse Reactions
The following adverse reactions are discussed in more detail elsewhere in the label:
Hypotension [see Warnings and Precautions (5.2)] Headache [see Warnings and Precautions (5.4)] Hypersensitivity [see Contraindications (4.4)]
Vertigo, dizziness, weakness, palpitation, and other manifestations of postural hypotension may develop occasionally, particularly in erect, immobile patients. Marked sensitivity to the hypotensive effects of nitrates (manifested by nausea, vomiting, weakness, diaphoresis, pallor, and collapse) may occur at therapeutic doses. Syncope due to nitrate vasodilatation has been reported.
Flushing, drug rash, and exfoliative dermatitis have been reported in patients receiving nitrate therapy.
^Nursing Mothers
Plasma levels of albuterol sulfate and HFA-134a after inhaled therapeutic doses are very low in humans, but it is not known whether the components of Albuterol Sulfate Inhalation Aerosol are excreted in human milk.
Because of the potential for tumorigenicity shown for albuterol in animal studies and lack of experience with the use of Albuterol Sulfate Inhalation Aerosol by nursing mothers, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Caution should be exercised when albuterol sulfate is administered to a nursing woman.
^Trueplus Glucose Tablets
15 g Fast acting Carbohydrates per Serving
Raises low blood sugar and boosts energy
Fat Free Gluten Free Sodium Free
ORANGE NATURALLY & ARTIFICIALLY FLAVORED
DO NOT USE IF PROTECTIVE SEAL IS BROKEN OR MISSING
QUESTIONS? Call 1-800-803-6025
INGREDIENTS: DEXTROSE (D-GLUCOSE), MALTODEXTRIN, CITRIC ACID, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLUOSE, NATURAL & ARTIFICIAL ORANGE FLAVOR, ASCORBIC ACID, YELLOW #6.
^Genitourinary System
Urinary frequency, difficult urination, urinary retention, early menses.
^7 Drug Interactions
Ergotamine: increased bioavailability of ergotamine. Avoid concomitant use. (7.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 10/2021
^ Severe Anemia
Nitroglycerin sublingual tablets are contraindicated in patients with severe anemia (large doses of nitroglycerin may cause oxidation of hemoglobin to methemoglobin and could exacerbate anemia).
^Use In Nursing Mothers
Because of the higher risk of antihistamines for infants generally, and for neonates and prematures in particular, antihistamine therapy is contraindicated in nursing mothers.
^Use In Neonates Or Premature Infants
This drug should not be used in neonates or premature infants.
^5 Warnings And Precautions
^Questions Or Comments?
1-800-719-9260
^1 Indications And Usage
Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.
^ Mechanism Of Action
Nitroglycerin forms free radical nitric oxide (NO) which activates guanylate cyclase, resulting in an increase of guanosine 3'5' monophosphate (cyclic GMP) in smooth muscle and other tissues. These events lead to dephosphorylation of myosin light chains, which regulate the contractile state in smooth muscle, and result in vasodilatation.
^Warnings
Do not use
Ask a doctor before use if the child has
Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers
When using this product
^Use In Labor And Delivery
Because of the potential for beta-agonist interference with uterine contractility, use of Albuterol Sulfate Inhalation Aerosol for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.
^Instructions For Use
EPINEPHRINE injection (ep-in-eph-rine)
for intramuscular or subcutaneous use
For allergic emergencies (anaphylaxis)
Read this Instructions for Use carefully before you use epinephrine injection and each time you get a refill. There may be new information. Before you need to use your epinephrine injection, make sure your healthcare provider shows you the right way to use it. Parents, caregivers, and others who may be in a position to administer epinephrine injection should also understand how to use it well. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. If you have any questions, ask your healthcare provider.
Your epinephrine injection
Step 1. Prepare epinephrine injection for injection
Note:
Step 2. Administer epinephrine injection
Step 3. Get emergency medical help right away. You may need further medical attention. You may need to use a second epinephrine injection if symptoms continue or recur.
Step 4. After use Disposal
Carefully cover the needle with the carrying case.
Note:
For more information and video instructions on the use of epinephrine injection, go to www.epinephrineautoinject.com or call 1-877-835-5472.
This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.
© 2021 Amneal Pharmaceuticals LLC. All rights reserved.
Manufactured by: Hospira, Inc. McPherson, KS 67460
Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807
Revised 02-2021-03
