^Povidine Iodine
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^Description
Dexamethasone Sodium Phosphate Injection, USP, is a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly.
Dexamethasone Sodium Phosphate, USP chemically is Pregna-1,4-diene-3,20-dione, 9-fluoro- 11,17-dihydroxy-16-methyl-21-(phosphonooxy)-, disodium salt, (11ß, 16α).
It occurs as a white to creamy white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.0 and 8.5. It has the following structural formula:
Each mL of Dexamethasone Sodium Phosphate Injection, USP (Preservative Free) contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 24.75 mg sodium citrate, dihydrate; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5.
Each mL Dexamethasone Sodium Phosphate Injection, USP (Preserved) contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 13.5 mg sodium citrate, dihydrate; 10 mg benzyl alcohol; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5.
^Ask A Doctor Before Use If You Have
ASK A DOCTOR BEFORE USE IF YOU HAVE:
^Dosage And Administration
Dexamethasone sodium phosphate injection, 10 mg/mL– For intravenous and intramuscular injection only.
Dexamethasone sodium phosphate injection can be given directly from the vial, or it can be added to Sodium Chloride Injection or Dextrose Injection and administered by intravenous drip.
Solutions used for intravenous administration or further dilution of this product should be preservative free when used in the neonate, especially the premature infant.
When it is mixed with an infusion solution, sterile precautions should be observed. Since infusion solutions generally do not contain preservatives, mixtures should be used within 24 hours.
DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE AND THE RESPONSE OF THE PATIENT.
Intravenous and Intramuscular Injection
The initial dosage of dexamethasone sodium phosphate injection varies from 0.5 to 9 mg a day depending on the disease being treated. In less severe diseases doses lower than 0.5 mg may suffice, while in severe diseases doses higher than 9 mg may be required.
The initial dosage should be maintained or adjusted until the patient’s response is satisfactory. If a satisfactory clinical response does not occur after a reasonable period of time, discontinue dexamethasone sodium phosphate injection and transfer the patient to other therapy.
After a favorable initial response, the proper maintenance dosage should be determined by decreasing the initial dosage in small amounts to the lowest dosage that maintains an adequate clinical response.
Patients should be observed closely for signs that might require dosage adjustment, including changes in clinical status resulting from remissions or exacerbations of the disease, individual drug responsiveness, and the effect of stress (e.g., surgery, infection, trauma). During stress it may be necessary to increase dosage temporarily.
If the drug is to be stopped after more than a few days of treatment, it usually should be withdrawn gradually.
When the intravenous route of administration is used, dosage usually should be the same as the oral dosage. In certain overwhelming, acute, life-threatening situations, however, administration in dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages. The slower rate of absorption by intramuscular administration should be recognized.
Shock
There is a tendency in current medical practice to use high (pharmacologic) doses of corticosteroids for the treatment of unresponsive shock. The following dosages of dexamethasone sodium phosphate injection have been suggested by various authors:
Administration of high dose corticosteroid therapy should be continued only until the patient’s condition has stabilized and usually not longer than 48 to 72 hours.
Although adverse reactions associated with high dose, short-term corticosteroid therapy are uncommon, peptic ulceration may occur.
Cerebral Edema
Dexamethasone sodium phosphate injection is generally administered initially in a dosage of 10 mg intravenously followed by four mg every six hours intramuscularly until the symptoms of cerebral edema subside. Response is usually noted within 12 to 24 hours and dosage may be reduced after two to four days and gradually discontinued over a period of five to seven days. For palliative management of patients with recurrent or inoperable brain tumors, maintenance therapy with 2 mg two or three times a day may be effective.
Acute Allergic Disorders
In acute, self-limited allergic disorders or acute exacerbations of chronic allergic disorders, the following dosage schedule combining parenteral and oral therapy is suggested:
Dexamethasone sodium phosphate injection, first day, 4 or 8 mg intramuscularly.
Dexamethasone tablets, 0.75 mg: second and third days, 4 tablets in two divided doses each day; fourth day, 2 tablets in two divided doses; fifth and sixth days, 1 tablet each day; seventh day, no treatment; eighth day, follow-up visit.
This schedule is designed to ensure adequate therapy during acute episodes, while minimizing the risk of overdosage in chronic cases.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.
^Indications & Usage
For use as an
^Directions
Wipe injection site vigorously and discard
^How Supplied
Dexamethasone Sodium Phosphate Injection, USP (Preservative Free) equivalent to 10 mg dexamethasone phosphate, is supplied in a single dose vial as follows:
Dexamethasone Sodium Phosphate Injection, USP (Preserved) equivalent to 10 mg dexamethasone phosphate, is supplied in a multiple dose vial as follows:
This container closure is not made with natural rubber latex.
Storage
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Sensitive to heat. Do not autoclave.
Protect from freezing.
Protect from light.
Single dose vials–Store in container until time of use. Discard unused portion.
Multiple dose vials–Store in container until contents are used.
^Mas Care-pak Dexamethasone mg/1ml Ndc# - -
NDC# 69677-071-02
MAS CARE-PAK DEXAMETHASONE 10MG/1ML
Rx-Only
Pak Contains:
2 Dexamethasone Sodium Phosphate Inj., USP 10mg/mL ( 1 mL )
1 Pair Nitrile Powder Free Sterile Glove ( M )
1 Povidone-lodine Swabsticks ( 3 Swabs )
3 Sterile Alcohol Prep Pads
1 Sterile Non-Woven Sponge
1 Sterile Sheer Plastic Bandage
1 Sterile Towel Drape
Needles and syringes not included
For professional office use only
Single use only
Distributed by MAS Pharma
Valencia, CA 91355
info@maspharma.com
^Contraindications
Systemic fungal infections (see WARNINGS regarding amphotericin B).
Hypersensitivity to any component of this product (see WARNINGS).
^Stop Use
STOP USE:
If irritation and redness develop - If condition persists for more than 72 hours, consult a physician.
^Do Not Use
DO NOT USE:
^Clinical Pharmacology
Dexamethasone sodium phosphate injection has a rapid onset but short duration of action when compared with less soluble preparations. Because of this, it is suitable for the treatment of acute disorders responsive to adrenocortical steroid therapy.
Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs, including dexamethasone, are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.
Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli.
At equipotent anti-inflammatory doses, dexamethasone almost completely lacks the sodium-retaining property of hydrocortisone and closely related derivatives of hydrocortisone.
^Dexamethasone Sodium Phosphate Injection, Usp Mg Per Ml
DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP 10 mg per mL
For IV or IM Use Only Rx only
1 mL Single Dose Vial
Preservative Free
Discard unused portion
PROTECT FROM LIGHT.
^Precautions
This product, like many other steroid formulations, is sensitive to heat. Therefore, it should not be autoclaved when it is desirable to sterilize the exterior of the vial.
Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including fever, myalgia, arthralgia, and malaise. This may occur in patients even without evidence of adrenal insufficiency.
There is an enhanced effect of corticosteroids in patients with hypothyroidism and in those with cirrhosis.
Corticosteroids should be used cautiously in patients with ocular herpes simplex for fear of corneal perforation.
The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction must be gradual.
Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.
Aspirin should be used within caution in conjunction with corticosteroids in hypoprothrombinemia.
Steroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess, or other pyogenic infection, also in diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, and myasthenia gravis. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving large doses of corticosteroids may be minimal or absent. Fat embolism has been reported as a possible complication of hypercortisonism.
When large doses are given, some authorities advise that antacids be administered between meals to help prevent peptic ulcer.
Steroids may increase or decrease motility and number of spermatozoa in some patients.
Phenytoin, phenobarbital, ephedrine, and rifampin may enhance the metabolic clearance of corticosteroids resulting in decreased blood levels and lessened physiologic activity, thus requiring adjustment in corticosteroid dosage. These interactions may interfere with dexamethasone suppression tests which should be interpreted with caution during administration of these drugs.
False negative results in the dexamethasone suppression test (DST) in patients being treated with indomethacin have been reported. Thus, results of the DST should be interpreted with caution in these patients.
The prothrombin time should be checked frequently in patients who are receiving corticosteroids and coumarin anticoagulants at the same time because of reports that corticosteroids have altered the response to these anticoagulants. Studies have shown that the usual effect produced by adding corticosteroids is inhibition of response to coumarins, although there have been some conflicting reports of potentiation not substantiated by studies.
When corticosteroids are administered concomitantly with potassium-depleting diuretics, patients should be observed closely for development of hypokalemia.
The slower rate of absorption by intramuscular administration should be recognized.
Information for Patients
Susceptible patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.
Pediatric Use
Growth and development of infants and children patients on prolonged corticosteroid therapy should be carefully followed.
^Sterile Alcohol Prep Pads
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^Keep Out Of Reach Of Children
Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center.
^Overdosage
Reports of acute toxicity and/or death following overdosage of glucocorticoids are rare. In the event of overdosage, no specific antidote is available; treatment is supportive and symptomatic.
The oral LD 50 of dexamethasone in female mice was 6.5 g/kg. The intravenous LD 50 of dexamethasone sodium phosphate in female mice was 794 mg/kg.
^Other Information
^Purpose
^Indications And Usage
Stop use and ask a doctor if:
^Adverse Reactions
Fluid and electrolyte disturbances:
Sodium retention
Fluid retention
Congestive heart failure in susceptible patients
Potassium loss
Hypokalemic alkalosis
Hypertension
Musculoskeletal:
Muscle weakness
Steroid myopathy
Loss of muscle mass
Osteoporosis
Vertebral compression fractures
Aseptic necrosis of femoral and humeral heads
Tendon rupture
Pathologic fracture of long bones
Gastrointestinal:
Peptic ulcer with possible subsequent perforation and hemorrhage
Perforation of the small and large bowel; particularly in patients with inflammatory
bowel disease
Pancreatitis
Abdominal distention
Ulcerative esophagitis
Dermatologic:
Impaired wound healing
Thin fragile skin
Petechiae and ecchymoses
Erythema
Increased sweating
May suppress reactions to skin tests
Burning or tingling, especially in the perineal area (after IV injection)
Other cutaneous reactions, such as allergic dermatitis, urticaria, angioneurotic edema
Neurologic:
Convulsions
Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after
treatment
Vertigo
Headache
Psychic disturbances
Endocrine:
Menstrual irregularities
Development of cushingoid state
Suppression of growth in pediatric patients
Secondary adrenocortical and pituitary unresponsiveness, particularly in times of
stress, as in trauma, surgery, or illness
Decreased carbohydrate tolerance
Manifestations of latent diabetes mellitus
Increased requirements for insulin or oral hypoglycemic agents in diabetics
Hirsutism
Ophthalmic:
Posterior subcapsular cataracts
Increased intraocular pressure
Glaucoma
Exophthalmos
Retinopathy of prematurity
Metabolic:
Negative nitrogen balance due to protein catabolism
Cardiovascular:
Myocardial rupture following recent myocardial infarction (see WARNINGS)
Hypertrophic cardiomyopathy in low birth weight infants
Other:
Anaphylactoid or hypersensitivity reactions
Thromboembolism
Weight gain
Increased appetite
Nausea
Malaise
Hiccups
The following additional adverse reactions are related to parenteral corticosteroid therapy:
Hyperpigmentation or hypopigmentation
Subcutaneous and cutaneous atrophy
Sterile abscess
Charcot-like arthropathy
^Dexamethasone Sodium Phosphate
For Intravenous or Intramuscular Use Only
Rx only
^References
^Warnings
KEEP OUT OF REACH OF CHILDREN
In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.
^Directions Povidone Iodine
Tear at notch, remove applicator, use only once.
As a first aid antiseptic
For preoperative patient skin preparation