Dalalone DP Uses

How do you administer this medicine?
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What is Dalalone DP?

Dalalone DP intravitreal implant is used to treat an eye disease called macular edema (swelling of the back of the eye). Macular edema occurs when a blood vessel in the eye is clogged. This causes vision changes that must be treated right away. Dalalone DP is a corticosteroid (steroid medicine) that helps reduce the swelling in the eye.

Dalalone DP intravitreal implant is also used to treat an eye disease called uveitis (swelling in the middle part of the eye). Dalalone DP is also used to treat diabetic macular edema in patients with artificial lens implant or are scheduled for cataract surgery.

Dalalone DP is to be given only by or under the supervision of your doctor.

Dalalone DP indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Intra-articular

Inflammatory joint diseases

Adult: 0.8-4 mg depending on the size of the affected joint. For soft-tissue inj, 2-6 mg may be used. May repeat inj every 3-5 days to every 2-3 wk.

Intravenous

Prophylaxis of nausea and vomiting associated with cytotoxic therapy

Adult: Prevention: 10-20 mg 15-30 minutes before admin of chemotherapy on each treatment day. For continuous infusion regimen: 10 mg every 12 hr on each treatment day. For midly emetogenic regimen: 4 mg every 4-6 hr.

Intravenous

Unresponsive shock

Adult: As phosphate: Initially, 40 mg or 1-6 mg/kg as a single IV inj, may repeat every 2-6 hr. Continue high-dose treatment only until patient's condition has stabilised and not to be continued beyond 48-72 hr.

Intravenous

Bacterial meningitis

Adult: 0.15 mg/kg 4 times daily, to be given 10-20 min before or with the 1st dose of anti-infective treatment. Treatment should be given for the first 2-4 days of the anti-infective treatment.

Child: As phosphate: 2 mth-18 yr: 150 mcg/kg every 6 hr for 4 days, starting before or with 1st dose of antibacterial treatment.

Ophthalmic

Ocular inflammation

Adult: As 0.1% suspension: Apply 1-2 drops into the affected eye/s 4-6 times daily in mild disease, up to hrly admin in more severe disease. As 0.05% ointment: Apply 0.5-1 inch ribbon of ointment into the conjunctival sac(s) up to 4 times daily. Reduce to once daily dosing once conditon has improved.

Oral

Anti-inflammatory

Adult: 0.75-9 mg daily in 2-4 divided doses; may also be given via IM/IV admin.

Child: 1 mth-18 yr: 10-100 mcg/kg daily in 1-2 divided doses via oral admin, adjusted according to response; up to 300 micrograms/kg daily may be used in emergency situations.

Oral

Screening test for Cushing's syndrome

Adult: 0.5 mg every 6 hr for 48 hr after determining baseline 24-hr urinary 17-hydroxycorticosteroid (17-OHCS) concentrations. During the second 24 hr of Dalalone DP admin, urine is collected and analysed for 17-OHCS. Alternatively, after a baseline plasma cortisol determination, 1 mg may be given at 11 pm and plasma cortisol determined at 8 am the next morning. Plasma cortisol and urinary output of 17-OHCS are depressed after Dalalone DP admin in normal individuals but remain at basal levels in patients with Cushing's syndrome.

Oral

Acute exacerbations in multiple sclerosis

Adult: 30 mg daily for 1 wk followed by 4-12 mg daily for 1 mth.

Child: 1 mth-12 yr: 100-400 mcg/kg daily in 1-2 divided doses; 12-18 yr: Initially 0.5-24 mg daily. Max. 24 mg daily.

Parenteral

Cerebral oedema caused by malignancy

Adult: As phosphate: 10 mg IV followed by 4 mg IM every 6 hr until response is achieved, usually after 12-24 hr. May reduce dosage after 2-4 days then gradually discontinued over 5-7 days. In severe cases, an initial dose of 50 mg IV may be given on day 1, with 8 mg every 2 hr, reduced gradually over 7-13 days. Maintenance dose: 2 mg 2-3 times daily.

Child: As phosphate: <35 kg: Initially 20 mg, then 4 mg every 3 hr for 3 days, then 4 mg every 6 hr for 1 day, then 2 mg every 6 hr for 4 days, then decrease by 1 mg daily. >35 kg: Initially 25 mg, then 4 mg every 2 hr for 3 days, then 4 mg every 4 hr for 1 day, then 4 mg every 6 hr for 4 days, then decrease by 2 mg daily. Doses are given via IV inj.

How should I use Dalalone DP?

Use Dalalone DP suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Dalalone DP suspension.

Uses of Dalalone DP in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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This medication is used to treat various conditions such as severe allergic reactions, arthritis, blood diseases, breathing problems, certain cancers, eye diseases, intestinal disorders, and skin diseases. It is also used to test for an adrenal gland disorder (Cushing's syndrome). It decreases your body's natural defensive response and reduces symptoms such as swelling and allergic-type reactions. Dalalone DP is a corticosteroid hormone (glucocorticoid). This injectable form of Dalalone DP is used when a similar drug cannot be taken by mouth or when a very fast response is needed, especially in patients with severe medical conditions. Talk to your doctor about the risks and benefits of Dalalone DP, especially if it is to be injected near your spine (epidural). Rare but serious side effects may occur with epidural use.

This drug may also be used with other medications as a replacement for certain hormones.

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 prevent nausea and vomiting caused by cancer chemotherapy.

How to use Dalalone DP injection

This medication is given by injection into a vein, muscle, joint, or skin wound as directed by your doctor. Follow your doctor's directions carefully. Dosage is based on your medical condition and response to treatment. Do not increase your dose or use this drug more often than prescribed without consulting your doctor. Some patients (especially newborns) should receive the preservative-free form of this drug. In these patients, when mixing this form of the drug, be sure to use IV fluid that is also preservative-free. Use these mixtures within 24 hours.

If this medication is injected into a joint, be careful how much pressure you put on that joint, even if it is feeling better. Ask your doctor how much you can move/use the joint while it is healing.

If you have been using this medication for a long time, do not suddenly stop using it without your doctor's approval. Your dose may need to be gradually decreased to reduce symptoms such as weakness, weight loss, nausea, or extreme tiredness.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Tell your doctor if your condition persists or worsens.

Dalalone DP description

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Dalalone DP is an intravitreal implant containing 0.7 mg (700 μg) Dalalone DP in the Dalalone DP solid polymer drug delivery system. Dalalone DP is preloaded into a single-use, specially designed DDS applicator to facilitate injection of the rod-shaped implant directly into the vitreous.

The Dalalone DP system contains poly (D,L-lactide-co-glycolide) PLGA intravitreal polymer matrix. Dalalone DP is preservative-free. The chemical name for Dalalone DP is pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydoxy-16-methyl-,(11β, 16α). Its molecular weight is 392.47; molecular formula: C22H29FO3.

Dalalone DP occurs as a white to cream-colored crystalline powder having not more than a slight odor, and is practically insoluble in water and very soluble in alcohol.

The PLGA matrix slowly degrades to lactic acid and glycolic acid.

Dalalone DP dosage

Dalalone DP Dosage

Generic name: Dalalone DP 20mg

Dosage form: tablets

Medically reviewed by Drugs.com. Last updated on Oct 17, 2019.

2.1 Recommended Dosage

The recommended dosage of Dalalone DP is 20 mg or 40 mg, orally, once daily, on specific days depending on the treatment regimen. Refer to the Prescribing Information of the other anti-myeloma products used in combination with Dalalone DP for specific Dalalone DP dosing. Dalalone DP can be administered with or without food.

Dose Modification for Elderly Patients

Dose-reduction for Dalalone DP is recommended for elderly patients, due to increased toxicity in these patients. Refer to the Prescribing Information of the other anti-myeloma products used as part of a combination regimen with Dalalone DP, for dosing recommendations in elderly patients.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Related questions

More about Dalalone DP (Dalalone DP)

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Dalalone DP interactions

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What other drugs will affect Dalalone DP?

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Tablet/Forte Tablet: Barbiturates, Phenytoin, Ephedrine, Carbamazepine, Rifampicin and Other Drugs that Stimulate Hepatic Metabolism: May lessen the effect of Dalalone DP due to enhancement of Dalalone DP metabolism. Increase in Dalalone DP dosage may be required.

CYP3A4 Inhibitors eg, Ketoconazole and Macrolide Antibiotics: May increase plasma concentrations of corticosteroids.

Indinavir, Erythromycin and Other Drugs Metabolized by CYP3A4: Dalalone DP is a moderate inducer of CYP3A4 and may increase clearance of these drugs, resulting in decreased plasma concentrations.

Oral Contraceptives and Estrogen:

Can cause alterations in plasma protein-binding and metabolism of corticosteroids which can result in exposure of women to increased levels of the unbound corticosteroid for long periods of time.

Aspirin: Concomitant use of aspirin or other nonsteroidal anti-inflammatory agents (NSAIDs) and corticosteroids increases the risk of gastrointestinal adverse effects. Use aspirin cautiously in conjunction with corticosteroids in hypoprothrombinemia.

Concomitant administration of Dalalone DP and aspirin may also cause changes in salicylate plasma protein-binding and its rate of metabolism. These changes cause lowering of plasma salicylate levels.

Warfarin: Co-administration of corticosteroids and warfarin usually results in decreased response to warfarin, although there have been conflicting results.

Monitor coagulation indices frequently to maintain the desired anticoagulant effect.

Potassium-Depleting Agents eg, Diuretics and Amphotericin-B: Observe patients closely for the development of hypokalemia. Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.

Anticholinesterase Agents: Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, withdraw anticholinesterase agents at least 24 hrs before initiating corticosteroid therapy.

Antacids: Large doses of antacids cause alteration in corticosteroid absorption.

Insulin: Concomitant administration of Dalalone DP and insulin generally requires higher doses of insulin.

Ketoconazole: Decreases the metabolism of certain corticosteroids by up to 60% leading to an increased risk of corticosteroid side effects.

Thalidomide: Toxic epidermal necrolysis has been reported when Dalalone DP was used concomitantly with thalidomide.

Indomethacin: May cause false negative results in the Dalalone DP suppression test (DST).

Other Interactions: Toxoids and Live or Inactivated Vaccines: Patients on prolonged corticosteroid therapy may exhibit diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response.

Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. If possible, postpone routine administration of vaccines or toxoids until corticosteroid therapy is discontinued.

Antidiabetic Agents: Dosage adjustment of antidiabetic agents may be required because corticosteroids may increase blood glucose concentrations.

Skin Tests: Corticosteroids may suppress reactions to skin tests.

Dalalone DP side effects

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What are the possible side effects of Dalalone DP?

Clinical Studies Experience: Treatment of Macular Edema: Clinical Studies 206207‐008 and 206207‐009 (Initial 6‐month Treatment Period): The clinical safety of Dalalone DP was assessed in 2 phase 3 randomized, double‐masked, sham-controlled studies in patients with macular edema following BRVO or CRVO. In both studies, a total of 421 patients were randomized and received Dalalone DP and 423 received sham.

The most frequently reported adverse reactions considered to be related to the intravitreal injection procedure rather than the Dalalone DP implant, included vitreous hemorrhage and conjunctival edema.

Intraocular Pressure in the Initial 6‐month Treatment Period of Studies 008 and 009: See Table 4.

The proportion of patients with increases from baseline IOP ≥10 mmHg in the study eye was significantly greater with Dalalone DP compared to sham at days 7, 30, 60, and 90. At day 180, there were no significant differences between Dalalone DP and sham.

The proportion of patients experiencing increased IOP with Dalalone DP peaked at day 60 and returned to baseline levels by day 180. Elevations of IOP either did not require treatment or were managed with topical IOP‐lowering medications in the vast majority of patients. During the initial treatment period, only 0.7% (3/421) of the patients who received Dalalone DP required laser or surgical procedures for management of elevated IOP in the study eye compared with 0.2% (1/423) with sham.

Systemic effects with Dalalone DP would be expected to be negligible due to low systemic levels (below the lower level of quantitation). The adverse event profile for BRVO patients was generally similar to that observed for CRVO patients, and to the overall population. The overall incidence of adverse events was higher for the subgroup of patients with CRVO, which is consistent with the nature of the disease as patients with CRVO are more likely to develop ocular adverse events than patients with BRVO, even when not treated.

Clinical Studies 206207‐008 and 206207‐009 (6‐month Open‐label Extension): The clinical safety of Dalalone DP was further assessed in a 6‐month open‐label (OL) extension of both phase 3 studies. Patients were eligible for re‐treatment if the BCVA was <84 letters or retinal thickness was >250 mcg in the central 1 mm macular subfield and the investigator considered that the procedure would not put the patient at significant risk. The re‐treated population consisted of patients who received Dalalone DP, or sham as their 1st injection, completed the initial treatment period at day 180, and then received Dalalone DP as their 2nd injection. A total of 997 patients received the Dalalone DP injection in the open‐label phase of both studies.

For those events reported at a rate of ≥1%, the types of events and their incidence following the 2nd injection were similar to those seen following the 1st injection with the exception of subcapsular cataract which were higher in patients who had received Dalalone DP as their 1st injection followed by Dalalone DP as the 2nd injection. More specifically, subcapsular cataracts in the study eye were notably more common in the Dalalone DP/Dalalone DP group (12.9%) compared to either sham/Dalalone DP (3.4%).

For events reported in ≤1% of patients, mostly in only 1 or 2 patients per group, some differences between the 1st and 2nd injection were seen. Review of these differences does not suggest a safety signal associated with repeat treatments.

The incidence of IOP increased was comparable between patients receiving either 1 or 2 doses of Dalalone DP.

Treatment of Uveitis: Clinical Study 206207‐014: The clinical safety of Dalalone DP was assessed in a multicenter, masked, and randomized, 26‐week phase 3 study in the treatment of non‐infectious uveitis affecting the posterior segment of the eye. A total of 76 patients were treated with Dalalone DP and 75 were treated with sham.

Intraocular Pressure in Study ‐014: As shown in Table 7, there were no clinically meaningful differences in the proportions of Dalalone DP and sham patients who experienced IOP at ≥25 mmHg or ≥35 mmHg in the study eye, at any visit. At week 26, no Dalalone DP patients and 3 sham patients had an IOP ≥25 mmHg; no patients had an IOP ≥35 mmHg.

Table 8 shows the proportion of patients with increases from baseline IOP ≥10 mmHg in the study eye was similar between Dalalone DP and sham, except at week 8 where significantly higher percentages were observed with Dalalone DP (9.6%) compared to sham (0%), p=0.013. At week 26, only 1 Dalalone DP patient and 2 sham patients showed an increase from baseline IOP ≥10 mmHg.

The proportion of Dalalone DP‐treated patients with increased IOP (≥25 mmHg) peaked at week 3 and returned to baseline by week 26. During the treatment period, no patients required incisional surgery for glaucoma. Three patients required laser iridotomies in the study eye for the treatment of pupillary block, iris bombe, and raised IOP.

Post-Marketing Experience: The following adverse reactions have been identified during post-marketing use of Dalalone DP in clinical practice. Because post-marketing reporting of these reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions. The reactions have been chosen for inclusion due to a combination of the frequency of reporting and/or possible causal connection to Dalalone DP.

Eye Disorders: Endophthalmitis: Hypotony of eye (associated with vitreous leakage due to injection), retinal detachment.

General Disorders and Administration Site Conditions: Complication of device insertion (implant misplacement), device dislocation with or without corneal edema.

Dalalone DP contraindications

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What is the most important information I should know about Dalalone DP?

You should not use this medication if you are allergic to Dalalone DP, or if you have a fungal infection anywhere in your body.

Before taking Dalalone DP, 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 Dalalone DP. Vaccines may not work as well while you are taking a steroid.

Do not stop using Dalalone DP suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Wear a medical alert tag or carry an ID card stating that you take Dalalone DP. Any medical care provider who treats you should know that you are using a steroid.



Active ingredient matches for Dalalone DP:

Dexamethasone


List of Dalalone DP substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
DECA FORTE Capsule/ Tablet / 1mg / 10 units (Merind Ltd (Wockhardt Ltd))$ 0.05
Deca Forte 1 mg Tablet (Merind Ltd (Wockhardt Ltd))$ 0.01
Gel; Topical; Dexamethasone 0.1%
Decadlin 0.5 mg
Decadolone 0.5 mg
Cream; Topical; Dexamethasone Sodium Phosphate 0.1% (Sidus)
Elixir; Oral; Dexamethasone Sodium Phosphate 0.5 mg / 5 ml (Sidus)
Injectable; Injection; Dexamethasone Sodium Phosphate 24 mg / ml (Sidus)
Injectable; Injection; Dexamethasone Sodium Phosphate 4 mg / ml (Sidus)
Ointment; Ophthalmic; Dexamethasone Sodium Phosphate 0.05% (Sidus)
Solution; Ophthalmic; Otic; Dexamethasone Sodium Phosphate 0.1% (Sidus)
Tablet; Oral; Dexamethasone Sodium Phosphate 0.25 mg (Sidus)
Tablet; Oral; Dexamethasone Sodium Phosphate 0.5 mg (Sidus)
Tablet; Oral; Dexamethasone Sodium Phosphate 0.75 mg (Sidus)
Tablet; Oral; Dexamethasone Sodium Phosphate 1.5 mg (Sidus)
Tablet; Oral; Dexamethasone Sodium Phosphate 4 mg (Sidus)
Tablet; Oral; Dexamethasone Sodium Phosphate 6 mg (Sidus)
Tablets; Oral; Dexamethasone Sodium Phosphate 0.25 mg (Sidus)
Tablets; Oral; Dexamethasone Sodium Phosphate 0.5 mg (Sidus)
Tablets; Oral; Dexamethasone Sodium Phosphate 0.75 mg (Sidus)
Tablets; Oral; Dexamethasone Sodium Phosphate 1.5 mg (Sidus)
Tablets; Oral; Dexamethasone Sodium Phosphate 4 mg (Sidus)
Tablets; Oral; Dexamethasone Sodium Phosphate 6 mg (Sidus)
100 tablet in 1 bottle (Sidus)
12 tablet in 1 dose pack (Sidus)
DECADRON INJECTION 1 vial / 2 ML injection each (Sidus)$ 0.16
DECADRON TABLET 1 strip / 10 tablets each (Sidus)$ 0.03
Decadron NA Injection (Sidus)$ 0.08
Decadron NA Tablet (Sidus)$ 0.00
Cream; Topical; Dexamethasone Sodium Phosphate 0.1% (Msd-chibret)
Elixir; Oral; Dexamethasone Sodium Phosphate 0.5 mg / 5 ml (Msd-chibret)

References

  1. DailyMed. "DEXAMETHASONE: 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).
  2. PubChem. "dexamethasone". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "dexamethasone". http://www.drugbank.ca/drugs/DB01234 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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