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What is Hydroval?
See also: Entyvio
Hydroval is a steroid medicine that is used in the treatment of many different conditions, including allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, multiple sclerosis, or lung disorders.
Hydroval is also used to replace steroids in people with adrenal insufficiency (decreased production of natural steroids by the adrenal glands).
Hydroval affects your immune system and is often used to treat certain blood cell disorders such as anemia (low red blood cells) or thrombocytopenia (low platelets).
Hydroval is also used in the treatment of certain cancers such as leukemia, lymphoma, and multiple myeloma.
Hydroval may also be used for purposes not listed in this medication guide.
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, the intravenous or intramusculat use of Solu-Hydroval Sterile Powder is indicated as follows:
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.
Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).
Primary or secondary adrenocortical insufficiency (Hydroval 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), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.
To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis.
Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia.
Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.
For the palliative management of leukemias and lymphomas.
Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy.
Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.
To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus.
Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.
How should I use Hydroval?
Use Hydroval solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Hydroval solution is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Hydroval solution at home, a health care provider will teach you how to use it. Be sure you understand how to use Hydroval 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 Hydroval 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 Hydroval solution, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Hydroval solution.
Uses of Hydroval in details
Hydroval is a natural substance (corticosteroid hormone) made by the adrenal gland. It is used to treat conditions such as arthritis, blood/hormone/immune system disorders, skin and eye conditions, breathing problems, cancer, and severe allergies. It decreases your immune system's response to various diseases to reduce symptoms such as pain, swelling and allergic-type reactions.
Hydroval is also used to treat low Hydroval levels caused by diseases of the adrenal gland (such as Addison's disease, adrenocortical insufficiency). Corticosteroids are needed in many ways for the body to function well. They are important for salt and water balance and keeping blood pressure normal.
How to use Hydroval
Take this medication by mouth, with food or milk to prevent stomach upset, exactly as directed by your doctor. Take this medication with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise.
Follow the dosing schedule carefully. The dosage and length of treatment are based on your medical condition and response to treatment. Your doctor may direct you to take Hydroval 1 to 4 times a day or take a single dose every other day. It may help to mark your calendar with reminders or use a pill box.
Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.
If you have used Hydroval regularly for a long time or in high doses, you may have withdrawal symptoms if the drug is suddenly stopped. To prevent withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness), your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away. See also Precautions section.
Tell your doctor if your condition persists or worsens.
Solu-Hydroval 100 mg contains Hydrocortisone sodium succinate equivalent to Hydroval 100 mg, monobasic sodium phosphate 1 mg, dibasic sodium 9 mg and sodium hydroxide 10%.
Solu-Hydroval 100 mg/2 mL contains Hydrocortisone sodium succinate equivalent to Hydroval 100 mg/2 mL, monobasic sodium phosphate 1 mg, dibasic sodium 10 mg and sodium hydroxide 10%.
Solu-Hydroval 250 mg/2 mL contains Hydrocortisone sodium succinate equivalent to Hydroval 250 mg/2 mL, monobasic sodium phosphate 2 mg, dibasic sodium phosphate 25 mg and sodium hydroxide 10%.
Solu-Hydroval 500 mg/4 mL contains Hydrocortisone sodium succinate equivalent to Hydroval 500 mg/4 mL, monobasic sodium phosphate 5 mg, dibasic sodium phosphate 52 mg and sodium hydroxide 10%.
Hydroval sodium succinate or pregn-4-ene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy; monosodium salt,(11β) is an anti-inflammatory adrenocortical steroid. This highly water-soluble sodium succinate ester of Hydroval permits the immediate IV administration of high doses of Hydroval in a small volume of diluent and is particularly useful where high blood levels of Hydroval are required rapidly.
When necessary, the pH of Solu-Hydroval was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7-8.
The use of Hydroval* Hydroval retention enema is predicated upon the concomitant use of modem supportive measures such as rational dietary control, sedatives, anldiarrheal agents, antibacterial therapy, blood replacement if necessary, etc.
The usual course of therapy is one Hydroval (Hydroval) * nightly for 21 days, or until the patient comes into remission both clinically and practologically. Clinical symptoms usually subside promptly within 3 to 5 days. Improvement in appearance of the mucosa, as seen by sigmoidoscope examination, may lag somewhat behind clinical improvement. Difficult cases may require as long as 2 or 3 months of Hydroval (Hydroval) * treatment. Where the course of therapy extends beyond 21 days, Hydroval (Hydroval) * should be discontinued gradually by reducing administration to every other night for 2 or 3 weeks.
If clinical or proctologic improvement fails to occur within 2 or 3 weeks after starting Hydroval® (Hydroval), discontinue its use.
Symptomatic improvement, evidenced by decreased diarrhea and bleeding; weight gain; improved appetite; lessened fever; and decrease in leukocytosis, may be misleading and should not be used as the sole criterion in judging efficacy. Sigmoidoscopic examination and X-ray visualization are essential for adequate monitoring of ulcerative colitis. Biopsy is useful for differential diagnosis. Patient instructions for administering Hydroval® (Hydroval) are enclosed in each box. It is recommended that the patient lie on their left side during administration and for 30 minutes thereafter, so that the fluid will distribute throughout the left colon. Every effort should be made to retain the enema for at least an hour and preferably, all night. This may be facilitated by prior sedation and/or antidianheal medication, especially early in therapy when the urge to evacuate is great.
Hydroval® Hydroval 100 mg retention enema, is supplied as disposable single-dose bottles with lubricated rectal applicator tips, in boxes of seven x 60 mL (NDC 62559-1110-7) and boxes of one x 60 mL (NDC 62559-1110-1). Store at controlled room temperature 20° - 25°C (68° - 77°F).
Manufactured by ANI Pharmaceuticals, Inc. Baltimore, MD 21244. Rev 09/07. FDA Rev date: 2/21/2008
With simultaneous use of Hydroval increases the toxicity of cardiac glycosides (because of the emerging hypokalemia increases the risk of arrhythmias); with acetylsalicylic acid - accelerates its excretion and reduces its concentration in blood plasma (with the abolition of Hydroval concentration of salicylates in the blood increases, and increases the risk of side effects); with paracetamol - increased risk of hepatotoxic action of paracetamol (induction of hepatic enzymes and formation of a toxic metabolite of paracetamol); with cyclosporine - increased side effects of Hydroval as a result of inhibition of its metabolism; with ketoconazole - increased side effects of Hydroval as a result of reduction of its clearance.
Hydroval Micronised Xepa-Soul Pattinson reduces the effectiveness of hypoglycemic; intensifies the effect of indirect anticoagulants of coumarin derivatives.
Hydroval reduces the effect of vitamin D on the absorption of calcium ions into the lumen of the intestine. Ergocalciferol and parathyroid hormone hinder the development of osteopathy caused by GCS.
Hydroval Micronised Xepa-Soul Pattinson increases the metabolism of isoniazid, meksiletina (especially in "fast acetylators"), which leads to a decrease in their plasma concentrations; increases (with prolonged therapy) the content of folic acid reduces the concentration of praziquantel in blood.
Hydroval in high doses reduces the effect somatropina.
Hypokalemia caused by GCS, may increase the severity and duration of muscle blockade on the background of muscle relaxants.
Antacids reduce the absorption of the GCS.
At simultaneous application with SCS thiazides, carbonic anhydrase inhibitors, other GCS, amphotericin B increase the risk of hypokalemia, drugs containing sodium ions - swelling and increase blood pressure.
NSAIDs and ethanol increases the risk of gastrointestinal ulcerations and bleeding, in combination with NSAIDs to treat arthritis may reduce the dose of GCS due to summation of therapeutic effect. Indomethacin displacing the SCS from its association with albumin, increases the risk of its side effects.
Amphotericin B and carbonic anhydrase inhibitors increase the risk of osteoporosis.
The therapeutic effect of GCS is reduced under the influence of inducers of microsomal liver enzymes (including phenytoin, barbiturates, ephedrine, theophylline, rifampin) due to increased rate of metabolism of these substances.
Inhibitors of the function of the adrenal cortex (including mitotan) may necessitate higher doses of GCS.
Clearance GCS increased against the background of preparations of thyroid hormones.
Immunosuppressants increase the risk of infection and lymphoma or other lymphoproliferative disorders associated with Epstein-Barr virus.
Estrogens (including oral contraceptives containing estrogen) reduce the clearance of GKS, lengthens T1/2 and their therapeutic and toxic effects. The appearance of hirsutism and acne promotes the simultaneous use of other steroid hormone funds - androgens, estrogens, anabolic steroids, oral contraceptives.
Tricyclic antidepressants may increase the severity of depression caused by GCS (not shown for the treatment of these side effects).
The risk of developing cataracts increases with the application against other GCS antipsychotic funds (neuroleptics), carbutamide and azathioprine. Simultaneous of Hydroval Micronised Xepa-Soul Pattinson with the appointment of m-cholinoblockers, as well as with means having m-anticholinergic action (including antihistamines, tricyclic antidepressants), with nitrates improves the intraocular pressure.
With simultaneous application of SCS with live vaccines and antiviral compared to other types of immunization increases the risk of activation of viruses and development of infections.
Hydroval side effects
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- HPA axis suppression. This has been observed in pediatric subjects using Hydroval
- Concomitant skin infections
- Skin irritation
Clinical Trials Experience: Adults
The following additional local adverse reactions have been reported infrequently with topical corticosteroids but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, drying, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
Clinical Trials Experience: Pediatrics
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety data derived from Hydroval (Hydroval butyrate) clinical trials reflect exposure to Hydroval twice daily for up to four weeks in separate clinical trials involving pediatric subjects 3 months to 18 years of age with mild to moderate atopic dermatitis.
Adverse reactions shown in the tables below include those for which there is some basis to believe there is a causal relationship to Hydroval (Hydroval butyrate).
Table 1 : Frequency of adverse reactions in pediatric subjects with mild to moderate atopic dermatitis
|Application site reactions, including application site folliculitis, irritation, dermatitis, or erythema||1.5%||1.5%|
The following adverse reactions have been identified during post approval use of Hydroval (Hydroval butyrate). Because these reactions are 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.
Skin: Erythema, Rash and Application site irritation.
You should not use this medication if you are allergic to Hydroval, or if you have a fungal infection anywhere in your body.
Before taking Hydroval, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.
Your steroid medication needs may change if you have any unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you during treatment.
Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.
Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.
Do not receive a "live" vaccine while you are taking Hydroval. Vaccines may not work as well while you are taking a steroid.
Do not stop using Hydroval suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.
Carry an ID card or wear a medical alert bracelet stating that you are taking a steroid, in case of emergency.
Active ingredient matches for Hydroval:
Hydrocortisone in Canada.
Hydrocortisone valerate in Canada.
|Unit description / dosage (Manufacturer)||Price, USD|
|Cream; Topical; Hydrocortisone Valerate 0.2%|
|Ointment; Topical; Hydrocortisone Valerate 0.2%|
List of Hydroval substitutes (brand and generic names):
|Hydrotopic Cream (Philippines)|
|Hydrotopic Cream 1 % x 500 g||$ 64.71|
|Hyoxysonum oint. (Latvia)|
|Hys NA Injection (Speciality Meditech Pvt Ltd)||$ 0.68|
|HYS 100 1GM INJECTION 1 vial / 1 injection each (Speciality Meditech Pvt Ltd)||$ 0.68|
|Hysone (Australia, South Korea)|
|Tablet; Oral; Hydrocortisone 20 mg (Saviour Speciality)|
|Tablet; Oral; Hydrocortisone 4 mg (Saviour Speciality)|
|Hysone 4mg TAB / 10 (Saviour Speciality)||$ 0.51|
|Hysone 16mg TAB / 10 (Saviour Speciality)||$ 1.75|
|Tablets; Oral; Hydrocortisone 20 mg (Saviour Speciality)|
|Tablets; Oral; Hydrocortisone 4 mg (Saviour Speciality)|
|Hysone 4 mg Tablet (Saviour Speciality)||$ 0.05|
|Hysone 16 mg Tablet (Saviour Speciality)||$ 0.17|
|Hytisone (Hong Kong, Thailand)|
|Hytisone 1 % x 5 g (Atlantic Lab)|
|Cream; Topical; Hydrocortisone Acetate 1% (Atlantic Lab)|
|Hytisone cream 1 % 5 g x 1's (Atlantic Lab)|
|Hytone (United States)|
|Cream; Topical; Hydrocortisone 1% (Dermik)|
|Cream; Topical; Hydrocortisone 2.5% (Dermik)|
|Lotion; Topical; Hydrocortisone 1% (Dermik)|
|Lotion; Topical; Hydrocortisone 2.5% (Dermik)|
|Ointment; Topical; Hydrocortisone 1% (Dermik)|
|Ointment; Topical; Hydrocortisone 2.5% (Dermik)|
|28 gram in 1 tube (Dermik)|
|57 gram in 1 tube (Dermik)|
|59 milliliter in 1 tube (Dermik)|
|100 mg x 1's (Evershine)|
|200 mg x 1's (Evershine)|
|Hyver 100mg INJ / 1 (Evershine)|
|Hyver 200mg INJ / 1 (Evershine)|
|Hyver 100mg INJ / 1 (Evershine)|
|Hyver 200mg INJ / 1 (Evershine)|
|Hyzonate (Pakistan, Philippines)|
|Hyzonate 100 mg x 1's|
|Hyzonate / vial 250 mg x 1's|
|Hyzonate 500 mg x 1's|
|ICORT TABLET 1 strip / 10 tablets each (M D C Pharmaceuticals P Ltd)||$ 0.54|
- DailyMed. "CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "hydrocortisone". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "hydrocortisone". http://www.drugbank.ca/drugs/DB00741 (accessed September 17, 2018).
ReviewsThe results of a survey conducted on ndrugs.com for Hydroval are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Hydroval. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
Consumer reported usefulNo survey data has been collected yet
Consumer reported price estimatesNo survey data has been collected yet
Consumer reported time for resultsNo survey data has been collected yet
1 consumer reported age
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Information checked by Dr. Sachin Kumar, MD Pharmacology