A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Celestone Indications, Dosage, Storage, Stability - Betamethasone (Injectable Suspension)
Celestone Indications, Dosage, Storage, Stability - Betamethasone (Injectable Suspension)
INDICATIONS
When oral therapy is not feasible and the strength, dosage form, and
route of administration of the drug reasonably lend the preparation to
the treatment of the condition, CELESTONE SOLUSPAN Injectable Suspension
for intramuscular use is indicated as follows:
Endocrine disorders: Primary or secondary adrenocortical
insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic
analogs may be used in conjunction with mineralocorticoids where applicable;
in infancy mineralocorticoid supplementation is of particular importance).
Acute adrenocortical insufficiency (hydrocortisone or cortisone is the
drug of choice; mineralocorticoid supplementation may be necessary, particularly
when synthetic analogs are used); preoperatively and in the event of serious
trauma or illness, in patients with known adrenal insufficiency or when
adrenocortical reserve is doubtful; shock unresponsive to conventional
therapy if adrenocortical insufficiency exists or is suspected; congenital
adrenal hyperplasia; nonsuppurative thyroiditis; hypercalcemia associated
with cancer.
Rheumatic disorders: As adjunctive therapy for short-term
administration (to tide the patient over an acute episode or exacerbation)
in: post-traumatic osteoarthritis; synovitis of osteoarthritis; rheumatoid
arthritis, including juvenile rheumatoid arthritis (selected cases may
require low-dose maintenance therapy); acute and subacute bursitis; epicondylitis;
acute nonspecific tenosynovitis; acute gouty arthritis; psoriatic arthritis;
ankylosing spondylitis.
Collagen diseases: During an exacerbation or as maintenance
therapy in selected cases of systemic lupus erythematosus, acute rheumatic
carditis.
Dermatologic diseases: Pemphigus, severe erythema multiforme
(Stevens-Johnson syndrome), exfoliative dermatitis, bullous dermatitis
herpetiformis, severe seborrheic dermatitis, severe psoriasis, mycosis
fungoides.
Allergic states: Control of severe or incapacitating allergic
conditions intractable to adequate trials of conventional treatment in:
bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness,
seasonal or perennial allergic rhinitis, drug hypersensitivity reactions,
urticarial transfusion reactions, acute noninfectious laryngeal edema
(epinephrine is the drug of first choice).
Ophthalmic diseases: Severe acute and chronic allergic
and inflammatory processes involving the eye, such as: herpes zoster ophthalmicus,
iritis and iridocyclitis, chorioretinitis, diffuse posterior uveitis and
choroiditis, optic neuritis, sympathetic ophthalmia, anterior segment
inflammation, allergic conjunctivitis, allergic corneal marginal ulcers,
keratitis.
Gastrointestinal diseases: To tide the patient over a critical
period of disease in: ulcerative colitis — (systemic therapy), regional
enteritis — (systemic therapy).
Respiratory diseases: Symptomatic sarcoidosis, berylliosis,
fulminating or disseminated pulmonary tuberculosis when used concurrently
with appropriate antituberculous chemotherapy, Loeffler’s syndrome not
manageable by other means, aspiration pneumonitis.
Hematologic disorders: Acquired (autoimmune) hemolytic
anemia, secondary thrombocytopenia in adults, erythroblastopenia (RBC
anemia), congenital (erythroid) hypoplastic anemia.
Neoplastic diseases: For palliative management of: leukemias
and lymphomas in adults, acute leukemia of childhood.
Edematous states: To induce diuresis or remission of proteinuria
in the nephrotic syndrome, without uremia, of the idiopathic type or that
due to lupus erythematosus.
Miscellaneous: Tuberculous meningitis with subarachnoid
block or impending block when used concurrently with appropriate antituberculous
chemotherapy, trichinosis with neurologic or myocardial involvement.
When the strength and dosage form of the drug lend the preparation to
the treatment of the condition, the intra-articular or soft tissue
administration of CELESTONE SOLUSPAN Injectable Suspension is indicated
as adjunctive therapy for short-term administration (to tide the patient
over an acute episode or exacerbation) in: synovitis of osteoarthritis,
rheumatoid arthritis, acute and subacute bursitis, acute gouty arthritis,
epicondylitis, acute nonspecific tenosynovitis, post-traumatic osteoarthritis.
When the strength and dosage form of the drug lend the preparation to
the treatment of the condition, the intralesional administration of CELESTONE
SOLUSPAN Injectable Suspension is indicated for: keloids; localized hypertrophic,
infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques,
granuloma annulare, and lichen simplex chronicus (neurodermatitis); discoid
lupus erythematosus; necrobiosis lipoidica diabeticorum; alopecia areata.
CELESTONE SOLUSPAN Injectable Suspension may also be useful in cystic
tumors of an aponeurosis or tendon (ganglia).
DOSAGE AND ADMINISTRATION
The initial dosage of CELESTONE SOLUSPAN Injectable Suspension may vary
from 0.5 to 9.0 mg per day depending on the specific disease entity being
treated. In situations of less severity, lower doses will generally suffice
while in selected patients higher initial doses may be required. Usually
the parenteral dosage ranges are one-third to one-half the oral dose given
every 12 hours. However, in certain overwhelming, acute, life-threatening
situations, administration in dosages exceeding the usual dosages may
be justified and may be in multiples of the oral dosages.
The initial dosage should be maintained or adjusted until a satisfactory
response is noted. If after a reasonable period of time there is a lack
of satisfactory clinical response, CELESTONE SOLUSPAN Injectable Suspension
should be discontinued and the patient transferred to other appropriate
therapy. It Should Be Emphasized That Dosage Requirements Are Variable
and Must Be Individualized on the Basis of the Disease Under Treatment
and the Response of the Patient. After a favorable response is noted,
the proper maintenance dosage should be determined by decreasing the initial
drug dosage in small decrements at appropriate time intervals until the
lowest dosage which will maintain an adequate clinical response is reached.
It should be kept in mind that constant monitoring is needed in regard
to drug dosage. Included in the situations which may make dosage adjustments
necessary are changes in clinical status secondary to remissions or exacerbations
in the disease process, the patient’s individual drug responsiveness,
and the effect of patient exposure to stressful situations not directly
related to the disease entity under treatment; in this latter situation
it may be necessary to increase the dosage of CELESTONE SOLUSPAN Injectable
Suspension for a period of time consistent with the patient’s condition.
If after long-term therapy the drug is to be stopped, it is recommended
that it be withdrawn gradually rather than abruptly.
If coadministration of a local anesthetic is desired, CELESTONE SOLUSPAN
Injectable Suspension may be mixed with 1 % or 2% lidocaine hydrochloride,
using the formulations which do not contain parabens. Similar local anesthetics
may also be used. Diluents containing methylparaben, propylparaben, phenol,
etc., should be avoided since these compounds may cause flocculation of
the steroid. The required dose of CELESTONE SOLUSPAN Injectable Suspension
is first withdrawn from the vial into the syringe. The local anesthetic
is then drawn in, and the syringe shaken briefly. Do not inject local
anesthetics into the vial of CELESTONE SOLUSPAN Injectable Suspension.
Bursitis, tenosynovitis, peritendinitis: In acute subdeltoid,
subacromial, olecranon, and prepatellar bursitis, one intra-bursal injection
of 1.0 mL CELESTONE SOLUSPAN Injectable Suspension can relieve pain and
restore full range of movement. Several intrabursal injections of corticosteroids
are usually required in recurrent acute bursitis and in acute exacerbations
of chronic bursitis. Partial relief of pain and some increase in mobility
can be expected in both conditions after one or two injections. Chronic
bursitis may be treated with reduced dosage once the acute condition is
controlled. In tenosynovitis and tendinitis, three or four local injections
at intervals of 1 to 2 weeks between injections are given in most cases.
Injections should be made into the affected tendon sheaths rather than
into the tendons themselves. In ganglions of joint capsules and tendon
sheaths, injection of 0.5 mL directly into the ganglion cysts has produced
marked reduction in the size of the lesions.
Rheumatoid arthritis and osteoarthritis: Following intra-articular
administration of 0.5 to 2.0 mL of CELESTONE SOLUSPAN Injectable Suspension,
relief of pain, soreness, and stiffness may be experienced. Duration of
relief varies widely in both diseases. Intra-articular Injection — CELESTONE
SOLUSPAN Injectable Suspension is well tolerated in joints and periarticular
tissues. There is virtually no pain on injection, and the “secondary flare”
that sometimes occurs a few hours after intra-articular injection of corticosteroids
has not been reported with CELESTONE SOLUSPAN Injectable Suspension. Using
sterile technique, a 20- to 24-gauge needle on an empty syringe is inserted
into the synovial cavity, and a few drops of synovial fluid are withdrawn
to confirm that the needle is in the joint. The aspirating syringe is
replaced by a syringe containing CELESTONE SOLUSPAN Injectable Suspension
and injection is then made into the joint.
Recommended Doses for Intra-articular Injection
|
Size of joint
|
Location
|
Dose (mL)
|
| Very Large |
Hip |
1.0-2.0
|
| Large |
Knee, Ankle, Shoulder |
1.0
|
| Medium |
Elbow, Wrist |
0.5-1.0
|
Small
(Metacarpophalangeal, interphalangeal)
(Sternoclavicular) |
Hand
Chest |
0.25-0.5
|
A portion of the administered dose of CELESTONE SOLUSPAN Injectable Suspension
is absorbed systemically following intra-articular injection. In patients
being treated concomitantly with oral or parenteral corticosteroids, especially
those receiving large doses, the systemic absorption of the drug should
be considered in determining intra-articular dosage.
Dermatologic conditions: In intralesional treatment, 0.2
mL/sq cm of CELESTONE SOLUSPAN Injectable Suspension is injected intradermally
(not subcutaneously) using a tuberculin syringe with a 25-gauge, 1/2-inch
needle. Care should be taken to deposit a uniform depot of medication
intradermally. A total of no more than 1.0 mL at weekly intervals is recommended.
Disorders of the foot: A tuberculin syringe with a 25-gauge,
3/4-inch needle is suitable for most injections into the foot. The following
doses are recommended at intervals of 3 days to a week.
|
Diagnosis
|
CELESTONE SOLUSPAN
Injectable Suspension Dose (mL)
|
Bursitis
under heloma durum or heloma molle
under calcaneal spur
over hallux rigidus or digiti quinti virus |
0.25-0.5
0.5
0.5
|
| Tenosynovitis, periostitis of cuboid |
0.5
|
| Acute gouty arthritis |
0.5-1.0
|
HOW SUPPLIED
CELESTONE SOLUSPAN Injectable Suspension, 5 mL multiple-dose vial; box
of one (NDC 0085-0566-05).
Shake well before using.
Store between 2° and 25°C (36° and 77°F).
Protect from light.
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